{"protocolSection":{"identificationModule":{"nctId":"NCT03464383","orgStudyIdInfo":{"id":"IRB00048584"},"secondaryIdInfos":[{"id":"5UL1TR001420-03","type":"NIH","link":"https://reporter.nih.gov/quickSearch/5UL1TR001420-03"}],"organization":{"fullName":"Wake Forest University Health Sciences","class":"OTHER"},"briefTitle":"Anxiety and Depression in Epilepsy: A Treatment Study","officialTitle":"Anxiety and Depression in Epilepsy: A Pilot Epileptologist-Driven Treatment Study"},"statusModule":{"statusVerifiedDate":"2019-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2018-05-07","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2019-09-20","type":"ACTUAL"},"completionDateStruct":{"date":"2019-09-20","type":"ACTUAL"},"studyFirstSubmitDate":"2018-03-07","studyFirstSubmitQcDate":"2018-03-07","studyFirstPostDateStruct":{"date":"2018-03-14","type":"ACTUAL"},"resultsFirstSubmitDate":"2020-09-18","resultsFirstSubmitQcDate":"2020-09-18","resultsFirstPostDateStruct":{"date":"2020-10-19","type":"ACTUAL"},"lastUpdateSubmitDate":"2020-09-18","lastUpdatePostDateStruct":{"date":"2020-10-19","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Wake Forest University Health Sciences","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"As a potential solution to address high rates of depression and anxiety seen in epilepsy patients and poor mental health care access, this randomized trial aims to study treatment for anxiety and depression in epilepsy taking place directly within the epilepsy clinic vs. psychiatry referral (typical care). Patients that meet eligibility criteria, including significant symptoms of depression and/or anxiety, will be randomized to the either the intervention group or the control group. Patients that do not meet eligibility requirement or decline the study intervention will have the option of participating in the survey arm of the study. The intervention will consist of an initial prescription for an FDA-approved medication to treat depression/anxiety and telephone-based chronic care management plan for repeated symptom measurement and side effect surveillance. The control group will receive usual care, which is a referral order to psychiatry placed by their treating neurologist. Participants in the survey arm of the study will complete a one time survey.","detailedDescription":"This trial is an innovative learning healthcare system approach to translate the concept of measurement-based depression care into a specialty clinic setting and extend the concept to treat depression and/or anxiety. The investigators' neurologist/APP-administered medication intervention utilizes FDA-approved drugs with advantageous features for use in epilepsy (escitalopram and venlafaxine) and a telephone-based chronic care management plan for repeated symptom measurement and side effect surveillance. The proposed intervention may overcome barriers to implementing mental health treatment interventions in generalized clinical settings by using healthcare providers commonly present in specialty clinics (physicians and APPs) along with a billable, best practices chronic care management intervention package and EMR-based clinical tools.To test this idea, the investigators seek to pilot a randomized trial of neurologist/APP medication management of depression and anxiety versus usual care with psychiatry referral in the epilepsy clinic, using epilepsy as a paradigm for chronic medical illness with high prevalence of psychiatric comorbidity. The optional survey arm is to help investigators understand the population that do not meet criteria or refuse intervention."},"conditionsModule":{"conditions":["Anxiety","Depression","Epilepsy"],"keywords":["Neurologic Disorders","Chronic Care","Management","Treatment","SSRI Medication","SNRI Medication","Learning Healthcare System"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","interventionModelDescription":"Participants will be randomized to one of two groups. Those randomized to the intervention group will receive an epileptologist-driven medication treatment for anxiety and depression, carried out directly in the epilepsy clinic during a regularly scheduled visit and supported by advanced practice provider (APP). Those randomized to the control group will receive an referral order to psychiatry placed by their epileptologist.","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"SINGLE","maskingDescription":"Outcome assessment phone calls for gathering scaled instrument scores will be carried out by a second study coordinator, blinded to treatment assignment.","whoMasked":["OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":69,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Epileptologist-Driven Treatment","type":"EXPERIMENTAL","description":"The intervention will consist of initiating a chronic care management plan in the epilepsy clinic and an initial prescription from the epileptologist for escitalopram 10mg daily. Escitalopram dose adjustment will be made based on biweekly repeated screening of anxiety and depression symptoms, as well as side effects identified on biweekly telephone calls or the 6-week advanced practice provider (APP) follow up visit. Escitalopram dose may be titrated up to a maximum of 20mg daily in 5-10mg increments every 2 weeks for treatment effect, or titrated down to 5mg if needed for adverse effects. If a participant is unable to tolerate escitalopram, then venlafaxine XR 37.5mg will be substituted, to be titrated in a similar manner biweekly based on side effects and anxiety and depression symptoms (with 37.5-75mg increment dose changes and maximum dose of 225mg daily).","interventionNames":["Drug: Escitalopram 10mg"]},{"label":"Standard of Care","type":"ACTIVE_COMPARATOR","description":"A psychiatry referral order placed by epileptologist under typical care circumstances (internal or external referral based on the participant's geographic preferences). Internal referrals will be processed by current clinic/institutional protocols. External referral orders will be printed and provided to the patient along with brief instructions on how to find a provider covered by the patient's insurance.","interventionNames":["Other: Referral to Psychiatry"]},{"label":"Survey Arm","type":"OTHER","description":"This option will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are found to be ineligible for intervention arms of the study, or those who are eligible for the intervention arm but decline to participate in the intervention.","interventionNames":["Other: Survey only"]}],"interventions":[{"type":"DRUG","name":"Escitalopram 10mg","description":"Participants will be given escitalopram 10mg by mouth daily and will be followed up with at 2, 4, 6, 8, and 10 weeks. Medication will be adjusted if side effects occur. If unable to tolerate escitalopram, then venlafaxine XR (Effexor XR) 37.5mg will be substituted.","armGroupLabels":["Epileptologist-Driven Treatment"],"otherNames":["Lexapro"]},{"type":"OTHER","name":"Referral to Psychiatry","description":"Participants randomized to control will have a psychiatry referral order placed by the treating epileptologist under typical care circumstances. This will be an internal or external referral order based on patient preference. If external, the order will be printed along with instructions for the patient to follow to find a provider covered by insurance.","armGroupLabels":["Standard of Care"]},{"type":"OTHER","name":"Survey only","description":"One time survey will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are ineligible for the treatment component of the study, or who decline the treatment study.","armGroupLabels":["Survey Arm"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Adherence to Intervention","description":"Percentage of participants who report taking the prescribed medication at 12 weeks and who have completed at least 2 of the chronic care management scheduled visits (telephone or clinic visit)","timeFrame":"12 weeks"}],"secondaryOutcomes":[{"measure":"Accrual","description":"Percentage of patients screened for the trial who are eligible","timeFrame":"baseline"},{"measure":"Participants Eligible for Consent Into Treatment Arms","description":"Percent eligible who consent to participate in treatment study","timeFrame":"baseline"},{"measure":"Retention","description":"Percentage of participants who complete the 12 week outcome assessment","timeFrame":"12 weeks"},{"measure":"Efficacy - Depression Symptoms","description":"Using Beck Depression Inventory-II (BDI-II) among those with high depression at baseline. The BDI-II is a self-report measure of depressive symptoms. Scores range from 0 to 63, with a higher score representing higher levels of depressive symptoms and higher scores representing worse outcome.","timeFrame":"baseline"},{"measure":"Efficacy - Depression Symptoms","description":"Beck Depression Inventory-II (BDI-II) among those with high depression at baseline. The BDI-II is a self-report measure of depressive symptoms. Scores range from 0 to 63, with a higher score representing higher levels of depressive symptoms and higher scores representing worse outcome.","timeFrame":"12 weeks"},{"measure":"Efficacy - Anxiety Symptoms","description":"Beck Anxiety Index (BAI) among those with high anxiety at baseline. The BAI is a self-report measure used for measuring the severity of anxiety. Scores range from 0 to 63, with a higher score representing more severe anxiety symptoms and higher scores representing worse outcomes.","timeFrame":"baseline"},{"measure":"Efficacy - Anxiety Symptoms","description":"Beck Anxiety Index (BAI) among those with high anxiety at baseline. The BAI is a self-report measure used for measuring the severity of anxiety. Scores range from 0 to 63, with a higher score representing more severe anxiety symptoms and higher scores representing worse outcomes.","timeFrame":"12 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Age 18 or older\n* Ability to take oral medication and the willing to adhere to the intervention regimen\n* Minimum of 1 prior clinic visit at the Comprehensive Epilepsy Center\n* Ability to complete questionnaires independently\n* Diagnosis of epilepsy: EEG with documented seizure or epileptiform discharges OR non-epileptiform EEG and seizure remission with antiseizure drug OR treating epileptologist's leading clinical impression is epilepsy\n* (Neurological Disorders Depression Inventory for epilepsy, NDDI-E score greater than 15 and/or Generalized Anxiety Disorder-7, GAD-7 score greater than or equal to 10\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Known allergic reactions to escitalopram or venlafaxine\n* Comorbid psychogenic nonepileptic seizures\n* Prior psychiatric hospitalization\n* Prior suicide attempt\n* History of manic or psychotic symptoms (past manic episode (SCID-I), or psychotic symptom screen positive)\n* Current treatment by a psychiatrist or counselor/therapist\n* Active suicidality at the time of screening\n* Current treatment with buspirone or an SSRI/SNRI/atypical antidepressant (specifically bupropion, fluoxetine, levomilnacipran, citalopram, milnacipran, desvenlafaxine, mirtazapine, duloxetine, paroxetine, escitalopram, sertraline, fluvoxamine, venlafaxine, vilazodone, vortioxetine)","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Heidi Munger Clary, MD","affiliation":"Wake Forest University Health Sciences","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Wake Forest Baptist Medical Center","city":"Winston-Salem","state":"North Carolina","zip":"27157","country":"United States","geoPoint":{"lat":36.09986,"lon":-80.24422}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Epileptologist-Driven Treatment","description":"The intervention will consist of initiating a chronic care management plan in the epilepsy clinic and an initial prescription from the epileptologist for escitalopram 10mg daily. Escitalopram dose may be titrated up to a maximum of 20mg daily in 5-10mg increments every 2 weeks for treatment effect, or titrated down to 5mg if needed for adverse effects. If a participant is unable to tolerate escitalopram, then venlafaxine XR 37.5mg will be substituted, to be titrated in a similar manner biweekly based on side effects and anxiety and depression symptoms (with 37.5-75mg increment dose changes and maximum dose of 225mg daily)."},{"id":"FG001","title":"Standard of Care","description":"A psychiatry referral order placed by epileptologist under typical care circumstances (internal or external referral based on the participant's geographic preferences). Internal referrals will be processed by current clinic/institutional protocols. External referral orders will be printed and provided to the patient along with brief instructions on how to find a provider covered by the patient's insurance.\n\nReferral to Psychiatry: Participants randomized to control will have a psychiatry referral order placed by the treating epileptologist under typical care circumstances. This will be an internal or external referral order based on patient preference. If external, the order will be printed along with instructions for the patient to follow to find a provider covered by insurance."},{"id":"FG002","title":"Survey Arm","description":"This option will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are found to be ineligible for intervention arms of the study, or those who are eligible for the intervention arm but decline to participate in the intervention.\n\nSurvey only: One time survey will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are ineligible for the treatment component of the study, or who decline the treatment study."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"63"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"63"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Epileptologist-Driven Treatment","description":"The intervention will consist of initiating a chronic care management plan in the epilepsy clinic and an initial prescription from the epileptologist for escitalopram 10mg daily. Escitalopram dose may be titrated up to a maximum of 20mg daily in 5-10mg increments every 2 weeks for treatment effect, or titrated down to 5mg if needed for adverse effects. If a participant is unable to tolerate escitalopram, then venlafaxine XR 37.5mg will be substituted, to be titrated in a similar manner biweekly based on side effects and anxiety and depression symptoms (with 37.5-75mg increment dose changes and maximum dose of 225mg daily)."},{"id":"BG001","title":"Standard of Care","description":"A psychiatry referral order placed by epileptologist under typical care circumstances (internal or external referral based on the participant's geographic preferences). Internal referrals will be processed by current clinic/institutional protocols. External referral orders will be printed and provided to the patient along with brief instructions on how to find a provider covered by the patient's insurance.\n\nReferral to Psychiatry: Participants randomized to control will have a psychiatry referral order placed by the treating epileptologist under typical care circumstances. This will be an internal or external referral order based on patient preference. If external, the order will be printed along with instructions for the patient to follow to find a provider covered by insurance."},{"id":"BG002","title":"Survey Arm","description":"This option will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are found to be ineligible for intervention arms of the study, or those who are eligible for the intervention arm but decline to participate in the intervention.\n\nSurvey only: One time survey will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are ineligible for the treatment component of the study, or who decline the treatment study."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"63"},{"groupId":"BG003","value":"69"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"63"},{"groupId":"BG003","value":"69"}]}],"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"61"},{"groupId":"BG003","value":"67"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"2"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"63"},{"groupId":"BG003","value":"69"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"39.0","spread":"6.1"},{"groupId":"BG001","value":"41.3","spread":"4.0"},{"groupId":"BG002","value":"42.2","spread":"13.5"},{"groupId":"BG003","value":"42.0","spread":"13.0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"63"},{"groupId":"BG003","value":"69"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"40"},{"groupId":"BG003","value":"42"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"23"},{"groupId":"BG003","value":"27"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"63"},{"groupId":"BG003","value":"69"}]}],"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"4"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"47"},{"groupId":"BG003","value":"53"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"12"},{"groupId":"BG003","value":"12"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"63"},{"groupId":"BG003","value":"69"}]}],"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"10"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"48"},{"groupId":"BG003","value":"53"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"4"}]}]}]},{"title":"Race and Ethnicity Not Collected","populationDescription":"Race and Ethnicity were not collected from any participant.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}],"categories":[{"measurements":[{"groupId":"BG003","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"63"},{"groupId":"BG003","value":"69"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"63"},{"groupId":"BG003","value":"69"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Adherence to Intervention","description":"Percentage of participants who report taking the prescribed medication at 12 weeks and who have completed at least 2 of the chronic care management scheduled visits (telephone or clinic visit)","populationDescription":"This outcome only pertains to the experimental arm. This was an intention-to treat analysis including all who were randomized to the intervention.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"12 weeks","groups":[{"id":"OG000","title":"Epileptologist-Driven Treatment","description":"The intervention will consist of initiating a chronic care management plan in the epilepsy clinic and an initial prescription from the epileptologist for escitalopram 10mg daily. Escitalopram dose may be titrated up to a maximum of 20mg daily in 5-10mg increments every 2 weeks for treatment effect, or titrated down to 5mg if needed for adverse effects. If a participant is unable to tolerate escitalopram, then venlafaxine XR 37.5mg will be substituted, to be titrated in a similar manner biweekly based on side effects and anxiety and depression symptoms (with 37.5-75mg increment dose changes and maximum dose of 225mg daily)."},{"id":"OG001","title":"Standard of Care","description":"A psychiatry referral order placed by epileptologist under typical care circumstances (internal or external referral based on the participant's geographic preferences). Internal referrals will be processed by current clinic/institutional protocols. External referral orders will be printed and provided to the patient along with brief instructions on how to find a provider covered by the patient's insurance.\n\nReferral to Psychiatry: Participants randomized to control will have a psychiatry referral order placed by the treating epileptologist under typical care circumstances. This will be an internal or external referral order based on patient preference. If external, the order will be printed along with instructions for the patient to follow to find a provider covered by insurance."},{"id":"OG002","title":"Survey Arm","description":"This option will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are found to be ineligible for intervention arms of the study, or those who are eligible for the intervention arm but decline to participate in the intervention.\n\nSurvey only: One time survey will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are ineligible for the treatment component of the study, or who decline the treatment study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}]},{"type":"SECONDARY","title":"Accrual","description":"Percentage of patients screened for the trial who are eligible","populationDescription":"Number of participants analyzed were not all consented or randomized. These were pre-screening numbers.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"baseline","groups":[{"id":"OG000","title":"Epileptologist-Driven Treatment Plus Standard of Care Arm","description":"Combined treatment arms"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"681"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"19"}]}]}]},{"type":"SECONDARY","title":"Participants Eligible for Consent Into Treatment Arms","description":"Percent eligible who consent to participate in treatment study","populationDescription":"This is the number who were pre-screened and who were eligible to consent.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"baseline","groups":[{"id":"OG000","title":"Epileptologist-Driven Treatment Plus Standard of Care Arm","description":"Combined treatment arms"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}]}]},{"type":"SECONDARY","title":"Retention","description":"Percentage of participants who complete the 12 week outcome assessment","populationDescription":"This was an intention-to treat analysis including all who were randomized to the intervention.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"12 weeks","groups":[{"id":"OG000","title":"Epileptologist-Driven Treatment","description":"The intervention will consist of initiating a chronic care management plan in the epilepsy clinic and an initial prescription from the epileptologist for escitalopram 10mg daily. Escitalopram dose may be titrated up to a maximum of 20mg daily in 5-10mg increments every 2 weeks for treatment effect, or titrated down to 5mg if needed for adverse effects. If a participant is unable to tolerate escitalopram, then venlafaxine XR 37.5mg will be substituted, to be titrated in a similar manner biweekly based on side effects and anxiety and depression symptoms (with 37.5-75mg increment dose changes and maximum dose of 225mg daily)."},{"id":"OG001","title":"Standard of Care","description":"A psychiatry referral order placed by epileptologist under typical care circumstances (internal or external referral based on the participant's geographic preferences). Internal referrals will be processed by current clinic/institutional protocols. External referral orders will be printed and provided to the patient along with brief instructions on how to find a provider covered by the patient's insurance.\n\nReferral to Psychiatry: Participants randomized to control will have a psychiatry referral order placed by the treating epileptologist under typical care circumstances. This will be an internal or external referral order based on patient preference. If external, the order will be printed along with instructions for the patient to follow to find a provider covered by insurance."},{"id":"OG002","title":"Survey Arm","description":"This option will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are found to be ineligible for intervention arms of the study, or those who are eligible for the intervention arm but decline to participate in the intervention.\n\nSurvey only: One time survey will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are ineligible for the treatment component of the study, or who decline the treatment study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"}]}]}]},{"type":"SECONDARY","title":"Efficacy - Depression Symptoms","description":"Using Beck Depression Inventory-II (BDI-II) among those with high depression at baseline. The BDI-II is a self-report measure of depressive symptoms. Scores range from 0 to 63, with a higher score representing higher levels of depressive symptoms and higher scores representing worse outcome.","populationDescription":"This outcome does not apply to survey arm. Baseline measurements were done before subjects in each treatment arm were lost to follow up and withdrew consent.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"baseline","groups":[{"id":"OG000","title":"Epileptologist-Driven Treatment","description":"The intervention will consist of initiating a chronic care management plan in the epilepsy clinic and an initial prescription from the epileptologist for escitalopram 10mg daily. Escitalopram dose may be titrated up to a maximum of 20mg daily in 5-10mg increments every 2 weeks for treatment effect, or titrated down to 5mg if needed for adverse effects. If a participant is unable to tolerate escitalopram, then venlafaxine XR 37.5mg will be substituted, to be titrated in a similar manner biweekly based on side effects and anxiety and depression symptoms (with 37.5-75mg increment dose changes and maximum dose of 225mg daily)."},{"id":"OG001","title":"Standard of Care","description":"A psychiatry referral order placed by epileptologist under typical care circumstances (internal or external referral based on the participant's geographic preferences). Internal referrals will be processed by current clinic/institutional protocols. External referral orders will be printed and provided to the patient along with brief instructions on how to find a provider covered by the patient's insurance.\n\nReferral to Psychiatry: Participants randomized to control will have a psychiatry referral order placed by the treating epileptologist under typical care circumstances. This will be an internal or external referral order based on patient preference. If external, the order will be printed along with instructions for the patient to follow to find a provider covered by insurance."},{"id":"OG002","title":"Survey Arm","description":"This option will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are found to be ineligible for intervention arms of the study, or those who are eligible for the intervention arm but decline to participate in the intervention.\n\nSurvey only: One time survey will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are ineligible for the treatment component of the study, or who decline the treatment study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"26.7","spread":"3.5"},{"groupId":"OG001","value":"21.0","spread":"7.2"}]}]}]},{"type":"SECONDARY","title":"Efficacy - Depression Symptoms","description":"Beck Depression Inventory-II (BDI-II) among those with high depression at baseline. The BDI-II is a self-report measure of depressive symptoms. Scores range from 0 to 63, with a higher score representing higher levels of depressive symptoms and higher scores representing worse outcome.","populationDescription":"This outcome does not apply to survey arm. 12 week measurements were done after subjects in each treatment arm were lost to follow up and withdrew consent.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"12 weeks","groups":[{"id":"OG000","title":"Epileptologist-Driven Treatment","description":"The intervention will consist of initiating a chronic care management plan in the epilepsy clinic and an initial prescription from the epileptologist for escitalopram 10mg daily. Escitalopram dose may be titrated up to a maximum of 20mg daily in 5-10mg increments every 2 weeks for treatment effect, or titrated down to 5mg if needed for adverse effects. If a participant is unable to tolerate escitalopram, then venlafaxine XR 37.5mg will be substituted, to be titrated in a similar manner biweekly based on side effects and anxiety and depression symptoms (with 37.5-75mg increment dose changes and maximum dose of 225mg daily)."},{"id":"OG001","title":"Standard of Care","description":"A psychiatry referral order placed by epileptologist under typical care circumstances (internal or external referral based on the participant's geographic preferences). Internal referrals will be processed by current clinic/institutional protocols. External referral orders will be printed and provided to the patient along with brief instructions on how to find a provider covered by the patient's insurance.\n\nReferral to Psychiatry: Participants randomized to control will have a psychiatry referral order placed by the treating epileptologist under typical care circumstances. This will be an internal or external referral order based on patient preference. If external, the order will be printed along with instructions for the patient to follow to find a provider covered by insurance."},{"id":"OG002","title":"Survey Arm","description":"This option will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are found to be ineligible for intervention arms of the study, or those who are eligible for the intervention arm but decline to participate in the intervention.\n\nSurvey only: One time survey will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are ineligible for the treatment component of the study, or who decline the treatment study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"25.0","spread":"5.7"},{"groupId":"OG001","value":"17.0","spread":"8.5"}]}]}]},{"type":"SECONDARY","title":"Efficacy - Anxiety Symptoms","description":"Beck Anxiety Index (BAI) among those with high anxiety at baseline. The BAI is a self-report measure used for measuring the severity of anxiety. Scores range from 0 to 63, with a higher score representing more severe anxiety symptoms and higher scores representing worse outcomes.","populationDescription":"This outcome does not apply to survey arm. Baseline measurements were done before subjects in each treatment arm were lost to follow up and withdrew consent.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"baseline","groups":[{"id":"OG000","title":"Epileptologist-Driven Treatment","description":"The intervention will consist of initiating a chronic care management plan in the epilepsy clinic and an initial prescription from the epileptologist for escitalopram 10mg daily. Escitalopram dose may be titrated up to a maximum of 20mg daily in 5-10mg increments every 2 weeks for treatment effect, or titrated down to 5mg if needed for adverse effects. If a participant is unable to tolerate escitalopram, then venlafaxine XR 37.5mg will be substituted, to be titrated in a similar manner biweekly based on side effects and anxiety and depression symptoms (with 37.5-75mg increment dose changes and maximum dose of 225mg daily)."},{"id":"OG001","title":"Standard of Care","description":"A psychiatry referral order placed by epileptologist under typical care circumstances (internal or external referral based on the participant's geographic preferences). Internal referrals will be processed by current clinic/institutional protocols. External referral orders will be printed and provided to the patient along with brief instructions on how to find a provider covered by the patient's insurance.\n\nReferral to Psychiatry: Participants randomized to control will have a psychiatry referral order placed by the treating epileptologist under typical care circumstances. This will be an internal or external referral order based on patient preference. If external, the order will be printed along with instructions for the patient to follow to find a provider covered by insurance."},{"id":"OG002","title":"Survey Arm","description":"This option will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are found to be ineligible for intervention arms of the study, or those who are eligible for the intervention arm but decline to participate in the intervention.\n\nSurvey only: One time survey will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are ineligible for the treatment component of the study, or who decline the treatment study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"18.0","spread":"9.6"},{"groupId":"OG001","value":"10.5","spread":"2.1"}]}]}]},{"type":"SECONDARY","title":"Efficacy - Anxiety Symptoms","description":"Beck Anxiety Index (BAI) among those with high anxiety at baseline. The BAI is a self-report measure used for measuring the severity of anxiety. Scores range from 0 to 63, with a higher score representing more severe anxiety symptoms and higher scores representing worse outcomes.","populationDescription":"This outcome does not apply to survey arm. 12 week measurements were done after subjects in each treatment arm were lost to follow up and withdrew consent.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"12 weeks","groups":[{"id":"OG000","title":"Epileptologist-Driven Treatment","description":"The intervention will consist of initiating a chronic care management plan in the epilepsy clinic and an initial prescription from the epileptologist for escitalopram 10mg daily. Escitalopram dose may be titrated up to a maximum of 20mg daily in 5-10mg increments every 2 weeks for treatment effect, or titrated down to 5mg if needed for adverse effects. If a participant is unable to tolerate escitalopram, then venlafaxine XR 37.5mg will be substituted, to be titrated in a similar manner biweekly based on side effects and anxiety and depression symptoms (with 37.5-75mg increment dose changes and maximum dose of 225mg daily)."},{"id":"OG001","title":"Standard of Care","description":"A psychiatry referral order placed by epileptologist under typical care circumstances (internal or external referral based on the participant's geographic preferences). Internal referrals will be processed by current clinic/institutional protocols. External referral orders will be printed and provided to the patient along with brief instructions on how to find a provider covered by the patient's insurance.\n\nReferral to Psychiatry: Participants randomized to control will have a psychiatry referral order placed by the treating epileptologist under typical care circumstances. This will be an internal or external referral order based on patient preference. If external, the order will be printed along with instructions for the patient to follow to find a provider covered by insurance."},{"id":"OG002","title":"Survey Arm","description":"This option will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are found to be ineligible for intervention arms of the study, or those who are eligible for the intervention arm but decline to participate in the intervention.\n\nSurvey only: One time survey will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are ineligible for the treatment component of the study, or who decline the treatment study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9.5","spread":"9.2"},{"groupId":"OG001","value":"11"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Baseline through 12 weeks for experimental and standard of care arms. For survey arm, from survey completion to time when incentive gift card communications were completed.","eventGroups":[{"id":"EG000","title":"Epileptologist-Driven Treatment","description":"The intervention will consist of initiating a chronic care management plan in the epilepsy clinic and an initial prescription from the epileptologist for escitalopram 10mg daily. Escitalopram dose may be titrated up to a maximum of 20mg daily in 5-10mg increments every 2 weeks for treatment effect, or titrated down to 5mg if needed for adverse effects. If a participant is unable to tolerate escitalopram, then venlafaxine XR 37.5mg will be substituted, to be titrated in a similar manner biweekly based on side effects and anxiety and depression symptoms (with 37.5-75mg increment dose changes and maximum dose of 225mg daily).","deathsNumAffected":0,"deathsNumAtRisk":3,"seriousNumAffected":0,"seriousNumAtRisk":3,"otherNumAffected":3,"otherNumAtRisk":3},{"id":"EG001","title":"Standard of Care","description":"A psychiatry referral order placed by epileptologist under typical care circumstances (internal or external referral based on the participant's geographic preferences). Internal referrals will be processed by current clinic/institutional protocols. External referral orders will be printed and provided to the patient along with brief instructions on how to find a provider covered by the patient's insurance.\n\nReferral to Psychiatry: Participants randomized to control will have a psychiatry referral order placed by the treating epileptologist under typical care circumstances. This will be an internal or external referral order based on patient preference. If external, the order will be printed along with instructions for the patient to follow to find a provider covered by insurance.","deathsNumAffected":0,"deathsNumAtRisk":3,"seriousNumAffected":0,"seriousNumAtRisk":3,"otherNumAffected":1,"otherNumAtRisk":3},{"id":"EG002","title":"Survey Arm","description":"This option will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are found to be ineligible for intervention arms of the study, or those who are eligible for the intervention arm but decline to participate in the intervention.\n\nSurvey only: One time survey will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are ineligible for the treatment component of the study, or who decline the treatment study.","deathsNumAffected":1,"deathsNumAtRisk":63,"seriousNumAffected":1,"seriousNumAtRisk":63,"otherNumAffected":0,"otherNumAtRisk":63}],"seriousEvents":[{"term":"sudden unexpected death in epilepsy","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":3},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":3},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":63}]}],"otherEvents":[{"term":"tooth pain from impacted wisdom tooth","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":3},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":3},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":63}]},{"term":"diarrhea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":3},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":3},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":63}]},{"term":"sexual dysfunction","organSystem":"Reproductive system and breast disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":3},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":3},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":63}]},{"term":"tremor","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":3},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":3},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":63}]},{"term":"night sweats","organSystem":"Endocrine disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":3},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":3},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":63}]},{"term":"headache","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":3},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":3},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":63}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Heidi M. Munger Clary, MD, MPH Associate Professor of Neurology","organization":"Wake Forest University School of Medicine","email":"hmungerc@wakehealth.edu","phone":"336-716-7110"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"ICF","hasProtocol":false,"hasSap":false,"hasIcf":true,"label":"Informed Consent Form","date":"2019-12-30","uploadDate":"2020-08-17T12:26","filename":"ICF_000.pdf","size":195917},{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2019-05-13","uploadDate":"2020-08-17T16:10","filename":"Prot_SAP_001.pdf","size":1284455}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D001008","term":"Anxiety Disorders"},{"id":"D003863","term":"Depression"},{"id":"D004827","term":"Epilepsy"},{"id":"D009422","term":"Nervous System Diseases"}],"ancestors":[{"id":"D001523","term":"Mental Disorders"},{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"},{"id":"D001927","term":"Brain Diseases"},{"id":"D002493","term":"Central Nervous System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D000089983","term":"Escitalopram"}],"ancestors":[{"id":"D011437","term":"Propylamines"},{"id":"D000588","term":"Amines"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D009570","term":"Nitriles"},{"id":"D001572","term":"Benzofurans"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"}]}},"hasResults":true}