{"protocolSection":{"identificationModule":{"nctId":"NCT01811147","orgStudyIdInfo":{"id":"IRB 12-1279"},"organization":{"fullName":"The Cleveland Clinic","class":"OTHER"},"briefTitle":"Differentiating Unipolar and Bipolar Depression in Young Adults Using fMRI","officialTitle":"Differentiating Unipolar and Bipolar Depression in Young Adults Using fMRI"},"statusModule":{"statusVerifiedDate":"2019-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2011-11"},"primaryCompletionDateStruct":{"date":"2018-06","type":"ACTUAL"},"completionDateStruct":{"date":"2018-06","type":"ACTUAL"},"studyFirstSubmitDate":"2011-12-12","studyFirstSubmitQcDate":"2013-03-12","studyFirstPostDateStruct":{"date":"2013-03-14","type":"ESTIMATED"},"resultsFirstSubmitDate":"2019-08-29","resultsFirstSubmitQcDate":"2019-11-26","resultsFirstPostDateStruct":{"date":"2019-12-02","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-11-26","lastUpdatePostDateStruct":{"date":"2019-12-02","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"The Cleveland Clinic","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true},"descriptionModule":{"briefSummary":"The purpose of the study is to find out what parts of the brain have increased or decreased activity and connectivity in individuals who have bipolar disorder, major depression, or no history of mood disorder. Another purpose of this study is to use MRI images to determine which young adults with major depression may be at greater risk for developing mild or more severe symptoms of mania which suggests a diagnosis of bipolar disorder.","detailedDescription":"The study involves two phases, phase one includes the screening visit and MRI. The second phase, for depression participants, involves in person follow ups for up to two years. The second phase, for healthy and bipolar participants, involves phone follow ups, every three months for up to two years. The purpose of this study is listed above. We plan to enroll 200 participants total."},"conditionsModule":{"conditions":["Bipolar Disorder","Major Depression"],"keywords":["Bipolar","Depression","Mania","Hypomania","fMRI","antidepressant"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"DIAGNOSTIC","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":192,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"High Risk Depression","type":"EXPERIMENTAL","description":"Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant.","interventionNames":["Drug: Selective Serotonin Reuptake Inhibitor (SSRI)"]},{"label":"Low Risk Depression","type":"EXPERIMENTAL","description":"Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant..","interventionNames":["Drug: Selective Serotonin Reuptake Inhibitor (SSRI)"]},{"label":"Healthy Control","type":"NO_INTERVENTION","description":"There is no intervention, but rather phone follow ups conducted as check ins to determine the continued eligibility of the healthy control participant."},{"label":"Bipolar","type":"NO_INTERVENTION","description":"Bipolar participants are checked in with via phone conversations every three months, and have the opportunity to be scheduled for non-study visits to manage their symptoms."}],"interventions":[{"type":"DRUG","name":"Selective Serotonin Reuptake Inhibitor (SSRI)","description":"Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months.","armGroupLabels":["High Risk Depression","Low Risk Depression"],"otherNames":["Serotonin-norepinephrine reuptake inhibitor"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"HAM-D 17 Item: Hamilton Depression Rating Scale","description":"Hamilton depression rating scale (17-item HAM-D):\n\nScores can range from 0 to 52: No depression (0-7); Mild depression (8-16); Moderate depression (17-23); and Severe depression (≥24).","timeFrame":"24 months"}],"secondaryOutcomes":[{"measure":"YMRS: Young Mania Rating Scale","description":"Young Mania Rating Scale: Scores can range from 0 to 60: In Remission/No Mania (0-8); Mild (9-12); Moderate (13-18); Severe (19-25); Very Severe (\\>25)","timeFrame":"24 months"}]},"eligibilityModule":{"eligibilityCriteria":"INCLUSION CRITERIA FOR BIPOLAR DEPRESSED PATIENTS:\n\n1. Ages 15 - 30 years (inclusive) and able to give voluntary informed consent (parents must also sign consent for subjects under 18)\n2. Satisfy criteria for Diagnostic and Statistical Manual 4th edition (DSM-IV-TR) for Bipolar I or II disorder\n3. Satisfy criteria for DSM-IV depressive episode-current\n4. 17-item Hamilton Depression Rating Scale \\> 15 but \\< 25;\n5. Young Mania Rating Scale score \\< 10\n6. Satisfy criteria to undergo an MRI scan based on MRI screening questionnaire.\n7. Able to be managed as outpatients during the study as ascertained by the following - i. Clinical Global Severity Scale \\< 5 i.e. moderately ill; ii. No significant suicidal or homicidal ideation or grossly disabled.\n\nINCLUSION CRITERIA FOR ALL UNIPOLAR DEPRESSED PATIENTS:\n\n1. Ages 15 - 30 years and able to give voluntary informed consent (Parental consent must also be obtained for those under 18 years old).\n2. Satisfy criteria for DSM-IV-TR Major Depressive Episode using a Structured Interview\n3. Never met criteria for mania or hypomania\n4. 17-item Hamilton Depression Rating Scale score (HDRS) \\> 15 and \\< 25.\n5. Young Mania Rating Scale (YMRS) score \\< 10\n6. Satisfy safety criteria to undergo an MRI scan\n7. Able to be managed as outpatients during the study as ascertained by the following - i. Clinical Global Severity Scale \\< 5 i.e. moderately ill; ii. No significant suicidal or homicidal ideation or grossly disabled\n\nADDITIONAL INCLUSION CRITERIA FOR HIGH RISK UD (HRUD) PATIENTS BESIDE THE INCLUSION CRITERIA FOR UD:\n\nAt least one of the following:\n\n1. Family history of bipolar disorder in at least one first degree relative\n2. History of any sub-threshold hypomania symptoms\n3. History of mood episode related psychotic symptoms\n\nADDITIONAL INCLUSION CRITERIA FOR LOW RISK UD (HRUD) PATIENTS BESIDE THE INCLUSION CRITERIA FOR UD:\n\n1. No family history of BD in a first or a second degree relative\n2. No past history of any sub-threshold hypomania symptoms\n3. No history of psychotic symptoms\n\nEXCLUSION CRITERIA FOR DEPRESSION AND BIPOLAR SUBJECTS:\n\n1. Meeting DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, pervasive developmental disorder.\n2. History of receiving electroconvulsive therapy in the past 1 year\n3. Use of neuroleptics, mood stabilizers or benzodiazepines in the past 2 weeks.\n4. Use of antidepressants in the past 2 weeks.\n5. If on fluoxetine in the past, then should not have been on this medication for 5 weeks.\n6. Acutely suicidal or homicidal or requiring inpatient treatment.\n7. Meeting DSM-IV criteria for other substance/alcohol dependence within the past 6 months or abuse in the past 3 months, excluding caffeine or nicotine. The criteria will be evaluated by interview and urinary toxicology screening. The use of caffeine or nicotine will be recorded.\n8. Use of alcohol in the past 1 week before the MRI scan.\n9. No serious acute or chronic medical or neurological illness, including previously known HIV positive status (due to possible CNS involvement) as assessed by history, physical examination and laboratory examination including EKG, CBC and blood chemistry.\n10. Current pregnancy or breast feeding.\n11. Metallic implants or other contraindication to MRI.\n\nINCLUSION CRITERIA FOR HEALTHY CONTROLS: Healthy subjects matched for age, gender and ethnicity will be included\n\n1. Ages 15 - 30 years (inclusive) and able to give voluntary informed consent (Parental consent must also be obtained for those under 18 years old)\n2. No current or past history of psychiatric illness or substance abuse or dependence.\n3. No current or past history of psychiatric illness or substance abuse or dependence in a first degree relative.\n\nEXCLUSION CRITERIA FOR HEALTHY CONTROLS:\n\n1. Pregnant or breast feeding.\n2. Metallic implants or other contraindication to MRI.\n3. Significant family history of psychiatric or neurological illness.\n4. Currently taking any prescription or centrally acting medications.\n5. Serious acute or chronic medical or neurological illness as assessed by history, physical examination and laboratory examination including CBC and blood chemistry.\n6. Use of alcohol in the past 1 week and not being able to avoid alcohol use during the course of the study.","healthyVolunteers":true,"sex":"ALL","minimumAge":"15 Years","maximumAge":"30 Years","stdAges":["CHILD","ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Amit Anand, MD","affiliation":"The Cleveland Clinic","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Cleveland Clinic Foundation Center for Behavioral Health","city":"Cleveland","state":"Ohio","zip":"44195","country":"United States","geoPoint":{"lat":41.4995,"lon":-81.69541}}]},"referencesModule":{"references":[{"pmid":"30579045","type":"DERIVED","citation":"Koirala P, Hu B, Altinay M, Li M, DiVita AL, Bryant KA, Karne HS, Fiedorowicz JG, Anand A. Sub-threshold bipolar disorder in medication-free young subjects with major depression: Clinical characteristics and antidepressant treatment response. J Psychiatr Res. 2019 Mar;110:1-8. doi: 10.1016/j.jpsychires.2018.12.006. Epub 2018 Dec 8."}]},"ipdSharingStatementModule":{"ipdSharing":"UNDECIDED"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"After enrollment 3 subject were excluded form the study since it was later discovered that they did not meet the criteria.","groups":[{"id":"FG000","title":"High Risk Depression","description":"Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant.\n\nSelective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months."},{"id":"FG001","title":"Low Risk Depression","description":"Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant..\n\nSelective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months."},{"id":"FG002","title":"Healthy Control","description":"There is no intervention, but rather phone follow ups conducted as check ins to determine the continued eligibility of the healthy control participant."},{"id":"FG003","title":"Bipolar","description":"Bipolar participants are checked in with via phone conversations every three months, and have the opportunity to be scheduled for non-study visits to manage their symptoms."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"51"},{"groupId":"FG001","numSubjects":"56"},{"groupId":"FG002","numSubjects":"49"},{"groupId":"FG003","numSubjects":"33"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"4"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"36"},{"groupId":"FG001","numSubjects":"45"},{"groupId":"FG002","numSubjects":"43"},{"groupId":"FG003","numSubjects":"29"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"High Risk Depression","description":"Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant.\n\nSelective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months."},{"id":"BG001","title":"Low Risk Depression","description":"Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant..\n\nSelective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months."},{"id":"BG002","title":"Healthy Control","description":"There is no intervention, but rather phone follow ups conducted as check ins to determine the continued eligibility of the healthy control participant."},{"id":"BG003","title":"Bipolar","description":"Bipolar participants are checked in with via phone conversations every three months, and have the opportunity to be scheduled for non-study visits to manage their symptoms."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"51"},{"groupId":"BG001","value":"56"},{"groupId":"BG002","value":"49"},{"groupId":"BG003","value":"33"},{"groupId":"BG004","value":"189"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"22.67","spread":"3.433"},{"groupId":"BG001","value":"25.27","spread":"3.661"},{"groupId":"BG002","value":"24.24","spread":"3.339"},{"groupId":"BG003","value":"23.52","spread":"3.784"},{"groupId":"BG004","value":"23.99","spread":"3.655"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"40"},{"groupId":"BG001","value":"38"},{"groupId":"BG002","value":"28"},{"groupId":"BG003","value":"22"},{"groupId":"BG004","value":"128"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"21"},{"groupId":"BG003","value":"11"},{"groupId":"BG004","value":"61"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Caucasian","categories":[{"measurements":[{"groupId":"BG000","value":"37"},{"groupId":"BG001","value":"50"},{"groupId":"BG002","value":"37"},{"groupId":"BG003","value":"26"},{"groupId":"BG004","value":"150"}]}]},{"title":"African American","categories":[{"measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"7"},{"groupId":"BG004","value":"30"}]}]},{"title":"Asian","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"9"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"51"},{"groupId":"BG001","value":"56"},{"groupId":"BG002","value":"49"},{"groupId":"BG003","value":"33"},{"groupId":"BG004","value":"189"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"HAM-D 17 Item: Hamilton Depression Rating Scale","description":"Hamilton depression rating scale (17-item HAM-D):\n\nScores can range from 0 to 52: No depression (0-7); Mild depression (8-16); Moderate depression (17-23); and Severe depression (≥24).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"24 months","groups":[{"id":"OG000","title":"High Risk Depression","description":"Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant.\n\nSelective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months."},{"id":"OG001","title":"Low Risk Depression","description":"Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant..\n\nSelective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months."},{"id":"OG002","title":"Healthy Control","description":"There is no intervention, but rather phone follow ups conducted as check ins to determine the continued eligibility of the healthy control participant."},{"id":"OG003","title":"Bipolar","description":"Bipolar participants are checked in with via phone conversations every three months, and have the opportunity to be scheduled for non-study visits to manage their symptoms."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"4"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.6","spread":"6.62"},{"groupId":"OG001","value":"4.91","spread":"4.11"},{"groupId":"OG002","value":"2.333","spread":"2.732"},{"groupId":"OG003","value":"3.75","spread":"4.992"}]}]}]},{"type":"SECONDARY","title":"YMRS: Young Mania Rating Scale","description":"Young Mania Rating Scale: Scores can range from 0 to 60: In Remission/No Mania (0-8); Mild (9-12); Moderate (13-18); Severe (19-25); Very Severe (\\>25)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"24 months","groups":[{"id":"OG000","title":"High Risk Depression","description":"Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant.\n\nSelective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months."},{"id":"OG001","title":"Low Risk Depression","description":"Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant..\n\nSelective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months."},{"id":"OG002","title":"Healthy Control","description":"There is no intervention, but rather phone follow ups conducted as check ins to determine the continued eligibility of the healthy control participant."},{"id":"OG003","title":"Bipolar","description":"Bipolar participants are checked in with via phone conversations every three months, and have the opportunity to be scheduled for non-study visits to manage their symptoms."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"4"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.2","spread":"0.561"},{"groupId":"OG001","value":"0","spread":"0"},{"groupId":"OG002","value":"0","spread":"0"},{"groupId":"OG003","value":"1.75","spread":"3.5"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"24 months","eventGroups":[{"id":"EG000","title":"High Risk Depression","description":"Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant.\n\nSelective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months.","deathsNumAffected":0,"deathsNumAtRisk":51,"seriousNumAffected":5,"seriousNumAtRisk":51,"otherNumAffected":3,"otherNumAtRisk":51},{"id":"EG001","title":"Low Risk Depression","description":"Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant..\n\nSelective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months.","deathsNumAffected":0,"deathsNumAtRisk":56,"seriousNumAffected":3,"seriousNumAtRisk":56,"otherNumAffected":4,"otherNumAtRisk":56},{"id":"EG002","title":"Healthy Control","description":"There is no intervention, but rather phone follow ups conducted as check ins to determine the continued eligibility of the healthy control participant.","deathsNumAffected":0,"deathsNumAtRisk":49,"seriousNumAffected":0,"seriousNumAtRisk":49,"otherNumAffected":0,"otherNumAtRisk":49},{"id":"EG003","title":"Bipolar","description":"Bipolar participants are checked in with via phone conversations every three months, and have the opportunity to be scheduled for non-study visits to manage their symptoms.","deathsNumAffected":0,"deathsNumAtRisk":33,"seriousNumAffected":0,"seriousNumAtRisk":33,"otherNumAffected":0,"otherNumAtRisk":33}],"seriousEvents":[{"term":"Sucidial Ideation","organSystem":"Psychiatric disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":51},{"groupId":"EG001","numAffected":2,"numAtRisk":56},{"groupId":"EG002","numAffected":0,"numAtRisk":49},{"groupId":"EG003","numAffected":0,"numAtRisk":33}]},{"term":"Hospitalization","organSystem":"Psychiatric disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":56},{"groupId":"EG002","numAffected":0,"numAtRisk":49},{"groupId":"EG003","numAffected":0,"numAtRisk":33}]},{"term":"Suicide Attempt","organSystem":"Psychiatric disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":56},{"groupId":"EG002","numAffected":0,"numAtRisk":49},{"groupId":"EG003","numAffected":0,"numAtRisk":33}]}],"otherEvents":[{"term":"Pregnancy","organSystem":"Pregnancy, puerperium and perinatal conditions","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":56},{"groupId":"EG002","numAffected":0,"numAtRisk":49},{"groupId":"EG003","numAffected":0,"numAtRisk":33}]},{"term":"Visit to Emergency Room","organSystem":"Social circumstances","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":56},{"groupId":"EG002","numAffected":0,"numAtRisk":49},{"groupId":"EG003","numAffected":0,"numAtRisk":33}]},{"term":"Substance Abuse Treatment","organSystem":"Psychiatric disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":2,"numAtRisk":56},{"groupId":"EG002","numAffected":0,"numAtRisk":49},{"groupId":"EG003","numAffected":0,"numAtRisk":33}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Amit Anand","organization":"Cleveland Clinic Foundation","email":"ananda@ccf.org","phone":"216-636-2840"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol: Image Acquisition - CCF","date":"2014-07-28","uploadDate":"2019-08-28T16:10","filename":"Prot_000.pdf","size":78341},{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan: Full Protocol","date":"2014-07-28","uploadDate":"2019-08-28T16:15","filename":"Prot_SAP_001.pdf","size":582042}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D001714","term":"Bipolar Disorder"},{"id":"D003865","term":"Depressive Disorder, Major"},{"id":"D003863","term":"Depression"},{"id":"D000087122","term":"Mania"}],"ancestors":[{"id":"D000068105","term":"Bipolar and Related Disorders"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D003866","term":"Depressive Disorder"},{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"},{"id":"D019954","term":"Neurobehavioral Manifestations"},{"id":"D009461","term":"Neurologic Manifestations"},{"id":"D009422","term":"Nervous System Diseases"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}]},"interventionBrowseModule":{"meshes":[{"id":"D017367","term":"Selective Serotonin Reuptake Inhibitors"}],"ancestors":[{"id":"D014179","term":"Neurotransmitter Uptake Inhibitors"},{"id":"D049990","term":"Membrane Transport Modulators"},{"id":"D045504","term":"Molecular Mechanisms of Pharmacological Action"},{"id":"D020228","term":"Pharmacologic Actions"},{"id":"D020164","term":"Chemical Actions and Uses"},{"id":"D018377","term":"Neurotransmitter Agents"},{"id":"D018490","term":"Serotonin Agents"},{"id":"D045505","term":"Physiological Effects of Drugs"}]}},"hasResults":true}