{"protocolSection":{"identificationModule":{"nctId":"NCT03388164","orgStudyIdInfo":{"id":"2017-007"},"organization":{"fullName":"Laureate Institute for Brain Research, Inc.","class":"OTHER"},"briefTitle":"Adherence to Antidepressant Treatment in Subjects With Depression","officialTitle":"Adherence to Antidepressant Treatment in Subjects With Depression"},"statusModule":{"statusVerifiedDate":"2020-11","overallStatus":"TERMINATED","whyStopped":"The study was terminated early based on the planned interim analysis that did not meet criteria for continuation.","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2018-01-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2019-05-15","type":"ACTUAL"},"completionDateStruct":{"date":"2019-05-15","type":"ACTUAL"},"studyFirstSubmitDate":"2017-12-22","studyFirstSubmitQcDate":"2017-12-22","studyFirstPostDateStruct":{"date":"2018-01-02","type":"ACTUAL"},"resultsFirstSubmitDate":"2020-11-17","resultsFirstSubmitQcDate":"2021-08-19","resultsFirstPostDateStruct":{"date":"2021-09-16","type":"ACTUAL"},"lastUpdateSubmitDate":"2021-08-19","lastUpdatePostDateStruct":{"date":"2021-09-16","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Laureate Institute for Brain Research, Inc.","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":true},"descriptionModule":{"briefSummary":"This study aims to determine whether a combination a first-line antidepressant plus \"RT2CK17\" in a capsule relative to a first-line antidepressant plus placebo in a capsule results in higher rates of medication adherence in individuals with moderate to severe depression. In this double-blind randomized placebo controlled trial, 100 individuals with a Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) scale score ≥ 14 will be enrolled to participate in an 8 week treatment study. Participants will be randomized with a 1-1 ratio to receive 5 milligrams (mg) \"RT2CK17\" + 10 mg escitalopram or placebo + 10 mg escitalopram to be taken orally once per day. Participants will undergo a 3 hour baseline evaluation visit at week 0, two 30-minute office visits (week 2 and 4), one 60-minute office visit (week 8) and three 5-minute phone calls (weeks 1, 3, and 6) during which clinical assessments and measures will be obtained. The trial is designed with two stages: 20 participants in Stage 1 will be used to estimate the adherence effect size; Stage 2 is designed with an interim analysis to test our hypotheses."},"conditionsModule":{"conditions":["Depression"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"OTHER","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":23,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Escitalopram + RT2CK17","type":"ACTIVE_COMPARATOR","description":"10mg escitalopram + 5mg RT2CK17 will be given orally and encapsulated into one capsule, once per day for 8 weeks. The capsules will be produced in the same manner as the placebo comparator by a local compounding pharmacy in Tulsa, Oklahoma.","interventionNames":["Drug: Escitalopram + RT2CK17"]},{"label":"Escitalopram + Placebo","type":"PLACEBO_COMPARATOR","description":"10mg escitalopram + 5mg placebo will be given orally and encapsulated into one capsule, once per day for 8 weeks. The capsules will be produced in the same manner as the active comparator by a local compounding pharmacy in Tulsa, Oklahoma.","interventionNames":["Drug: Escitalopram + Placebo"]}],"interventions":[{"type":"DRUG","name":"Escitalopram + RT2CK17","description":"Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6.","armGroupLabels":["Escitalopram + RT2CK17"]},{"type":"DRUG","name":"Escitalopram + Placebo","description":"Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6.","armGroupLabels":["Escitalopram + Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Rate of Adherence","description":"To determine whether RT2CK17 + escitalopram results in higher rates of medication adherence relative to placebo + escitalopram as measured by percentage pill count","timeFrame":"8 weeks"}],"secondaryOutcomes":[{"measure":"Adherence Consistency","description":"To determine whether RT2CK17 + escitalopram results in greater consistency of adherence relative to placebo + escitalopram as measured by percentage of doses taken on schedule within 25% of the expected time interval, defined as +/- 6 hours from the participant's breakfast time","timeFrame":"8 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Baseline QIDS-SR ≥ 14 (moderate depression)\n* Age 18 - 65\n* Written Informed Consent\n* Major Depressive Disorder, single-episode/recurrent, not in remission\n\nExclusion Criteria:\n\n* RT2CK17-related exclusions\n* Uncontrolled hyperthyroidism\n* Glaucoma\n* Motor tics\n* Monoamine oxidase inhibitor treatment\n* Serious coronary artery disease, cardiomyopathy, serious cardiac arrhythmias\n* Uncontrolled hypertension\n* Peripheral vasculopathy\n* Pregnancy\n* Bipolar Disorder\n* Psychotic Disorder\n* History of intolerability of study medications\n* Currently taking psychiatric medications\n* Current Substance Use Disorder (other than nicotine)\n* Current Alcohol Use Disorder","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Martin P Paulus, M.D.","affiliation":"Laureate Institute for Brain Research","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Laureate Institute for Brain Research","city":"Tulsa","state":"Oklahoma","zip":"74136","country":"United States","geoPoint":{"lat":36.15398,"lon":-95.99277}}]},"referencesModule":{"references":[{"pmid":"34798853","type":"DERIVED","citation":"Paulus MP, Kuplicki R, Victor TA, Yeh HW, Khalsa SS. Methylphenidate augmentation of escitalopram to enhance adherence to antidepressant treatment: a pilot randomized controlled trial. BMC Psychiatry. 2021 Nov 19;21(1):582. doi: 10.1186/s12888-021-03583-7."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Three individuals were excluded prior to group assignment:\n\n2- did not meet inclusion criteria (alcohol use, low TSH)\n\n1- declined to participate","groups":[{"id":"FG000","title":"Escitalopram + RT2CK17","description":"10mg escitalopram + 5mg RT2CK17 will be given orally and encapsulated into one capsule, once per day for 8 weeks. The capsules will be produced in the same manner as the placebo comparator by a local compounding pharmacy in Tulsa, Oklahoma.\n\nEscitalopram + RT2CK17: Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6."},{"id":"FG001","title":"Escitalopram + Placebo","description":"10mg escitalopram + 5mg placebo will be given orally and encapsulated into one capsule, once per day for 8 weeks. The capsules will be produced in the same manner as the active comparator by a local compounding pharmacy in Tulsa, Oklahoma.\n\nEscitalopram + Placebo: Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"9"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Escitalopram + RT2CK17","description":"10mg escitalopram + 5mg RT2CK17 will be given orally and encapsulated into one capsule, once per day for 8 weeks. The capsules will be produced in the same manner as the placebo comparator by a local compounding pharmacy in Tulsa, Oklahoma.\n\nEscitalopram + RT2CK17: Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6."},{"id":"BG001","title":"Escitalopram + Placebo","description":"10mg escitalopram + 5mg placebo will be given orally and encapsulated into one capsule, once per day for 8 weeks. The capsules will be produced in the same manner as the active comparator by a local compounding pharmacy in Tulsa, Oklahoma.\n\nEscitalopram + Placebo: Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"20"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"31.5","spread":"10.7"},{"groupId":"BG001","value":"31.0","spread":"10.6"},{"groupId":"BG002","value":"31.3","spread":"10.4"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"15"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"17"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Rate of Adherence","description":"To determine whether RT2CK17 + escitalopram results in higher rates of medication adherence relative to placebo + escitalopram as measured by percentage pill count","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage of pills taken","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"Escitalopram + RT2CK17","description":"10mg escitalopram + 5mg RT2CK17 will be given orally and encapsulated into one capsule, once per day for 8 weeks. The capsules will be produced in the same manner as the placebo comparator by a local compounding pharmacy in Tulsa, Oklahoma.\n\nEscitalopram + RT2CK17: Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6."},{"id":"OG001","title":"Escitalopram + Placebo","description":"10mg escitalopram + 5mg placebo will be given orally and encapsulated into one capsule, once per day for 8 weeks. The capsules will be produced in the same manner as the active comparator by a local compounding pharmacy in Tulsa, Oklahoma.\n\nEscitalopram + Placebo: Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"9"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"93.5","spread":"7.6"},{"groupId":"OG001","value":"97.6","spread":"6.5"}]}]}]},{"type":"SECONDARY","title":"Adherence Consistency","description":"To determine whether RT2CK17 + escitalopram results in greater consistency of adherence relative to placebo + escitalopram as measured by percentage of doses taken on schedule within 25% of the expected time interval, defined as +/- 6 hours from the participant's breakfast time","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage of pills taken on time","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"Escitalopram + RT2CK17","description":"10mg escitalopram + 5mg RT2CK17 will be given orally and encapsulated into one capsule, once per day for 8 weeks. The capsules will be produced in the same manner as the placebo comparator by a local compounding pharmacy in Tulsa, Oklahoma.\n\nEscitalopram + RT2CK17: Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6."},{"id":"OG001","title":"Escitalopram + Placebo","description":"10mg escitalopram + 5mg placebo will be given orally and encapsulated into one capsule, once per day for 8 weeks. The capsules will be produced in the same manner as the active comparator by a local compounding pharmacy in Tulsa, Oklahoma.\n\nEscitalopram + Placebo: Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"9"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"89.8","spread":"8.2"},{"groupId":"OG001","value":"93.6","spread":"8.4"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"8 weeks","eventGroups":[{"id":"EG000","title":"Escitalopram + RT2CK17","description":"10mg escitalopram + 5mg RT2CK17 will be given orally and encapsulated into one capsule, once per day for 8 weeks. The capsules will be produced in the same manner as the placebo comparator by a local compounding pharmacy in Tulsa, Oklahoma.\n\nEscitalopram + RT2CK17: Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6.","deathsNumAffected":0,"deathsNumAtRisk":10,"seriousNumAffected":0,"seriousNumAtRisk":10,"otherNumAffected":0,"otherNumAtRisk":10},{"id":"EG001","title":"Escitalopram + Placebo","description":"10mg escitalopram + 5mg placebo will be given orally and encapsulated into one capsule, once per day for 8 weeks. The capsules will be produced in the same manner as the active comparator by a local compounding pharmacy in Tulsa, Oklahoma.\n\nEscitalopram + Placebo: Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6.","deathsNumAffected":0,"deathsNumAtRisk":10,"seriousNumAffected":0,"seriousNumAtRisk":10,"otherNumAffected":0,"otherNumAtRisk":10}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"The study was terminated early based on the planned interim analysis."},"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Teresa Victor","organization":"Laureate Institute for Brain Research","email":"tvictor@laureateinstitute.org","phone":"918-502-5108"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2017-11-07","uploadDate":"2020-11-17T15:49","filename":"Prot_SAP_000.pdf","size":714839},{"typeAbbrev":"ICF","hasProtocol":false,"hasSap":false,"hasIcf":true,"label":"Informed Consent Form","date":"2017-11-30","uploadDate":"2020-11-17T15:49","filename":"ICF_001.pdf","size":383639}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13","submissionTracking":{"firstMcpInfo":{"postDateStruct":{"date":"2020-12-11","type":"ACTUAL"}}}},"conditionBrowseModule":{"meshes":[{"id":"D003863","term":"Depression"}],"ancestors":[{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"}]},"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}