{"protocolSection":{"identificationModule":{"nctId":"NCT00464711","orgStudyIdInfo":{"id":"2006-P-001295"},"organization":{"fullName":"Massachusetts General Hospital","class":"OTHER"},"briefTitle":"Brain GABA Levels and Treatment Response in Major Depressive Disorder","officialTitle":"Brain GABA Levels and Treatment Response in Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2016-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2006-09"},"primaryCompletionDateStruct":{"date":"2009-09","type":"ACTUAL"},"completionDateStruct":{"date":"2009-09","type":"ACTUAL"},"studyFirstSubmitDate":"2007-04-23","studyFirstSubmitQcDate":"2007-04-23","studyFirstPostDateStruct":{"date":"2007-04-24","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-09-15","resultsFirstSubmitQcDate":"2016-11-04","resultsFirstPostDateStruct":{"date":"2017-01-04","type":"ESTIMATED"},"lastUpdateSubmitDate":"2016-11-04","lastUpdatePostDateStruct":{"date":"2017-01-04","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"David Mischoulon, MD","investigatorTitle":"David Mischoulon, M.D.","investigatorAffiliation":"Massachusetts General Hospital"},"leadSponsor":{"name":"Massachusetts General Hospital","class":"OTHER"},"collaborators":[{"name":"Mclean Hospital","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This study will evaluate changes in brain gamma-aminobutyric acid (GABA) levels due to treatment with escitalopram in people with major depressive disorder.","detailedDescription":"Major depressive disorder (MDD) is a severe form of depression. MDD can significantly interfere with an individual's thoughts, behavior, mood, and physical health. People who suffer from MDD often experience feelings of worthlessness; they may feel hopeless and may be unable to cope with problems in their life. In addition, they often experience sleep disruption, loss of appetite, and chronic pain.\n\nThe purpose of the study is to compare images taken of the brains of people who are depressed and the brains of healthy volunteers. Specifically, we want to see if symptoms of depression are related to a decrease in a brain chemical called GABA. We measure the concentration of GABA using a brain-scanning device called \"magnetic resonance spectroscopy\" (or \"MRS\"), which is a type of MRI.\n\nThe study lasts for 14 weeks and involves 8 visits to our MGH clinic in Boston. The first visit is the screening visit, which can last up to 3 hours. The rest of the visits are about a half hour long and take place every other week. In addition to these 8 visits, there are also 2 visits to McLean Hospital Brain Imaging Center for the MRS scans. The first scan takes place within a few days after the screening visit, and the second scan will be at the end of the 14 weeks. Each scan visit lasts between an hour and a half and two hours. Subjects are reimbursed $50 per MRS scan and $25 per visit to McLean to cover travel costs.\n\nAll subjects in this study will receive escitalopram (or Lexapro), which is an antidepressant medication approved by the Food and Drug Administration. Subjects start at 10 mg daily of the escitalopram, but may be increased up to 30 mg if the study doctor thinks it is appropriate."},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["depression","biology"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":40,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Escitalopram","type":"OTHER","description":"single arm","interventionNames":["Drug: Escitalopram"]}],"interventions":[{"type":"DRUG","name":"Escitalopram","description":"Dose determined per clinical discretion. All participants begin on 10mg po qd of escitalopram, and can increase the dose to 30mg po qd over the 12 weeks of the study.","armGroupLabels":["Escitalopram"],"otherNames":["Lexapro"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Response and Remitter Status at Endpoint, Based on Change in Depression Severity Rating Scores","description":"The primary outcome in this study was based on the Hamilton Rating Scale for Depression, 17 items (HAMD-17). Clinical Response status was defined as \\> 50 % reduction in HAMD-17 scores from baseline to endpoint. Clinical Remitter status was defined as endpoint HAMD-17 score \\< 8.\n\n40 patients (21 female) with major depressive disorder (MDD) started the 12 week study treatment with escitalopram, 25 patients (15 female) completed the 12 weeks.","timeFrame":"12 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Meet diagnostic criteria for current Major Depressive Disorder\n* Men or women aged 18-65\n* Medication-free for one week prior to the start of the study\n* Agrees to use an effective form of contraception throughout the study\n\nExclusion Criteria:\n\n* Anyone who is suicidal\n* Pregnant or breastfeeding women\n* Anyone with a serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease\n* Anyone with a history of seizure disorder or hypothyroidism\n* Anyone with a history of psychiatric disorders including bipolar disorder, schizophrenia, psychoses, or substance abuse (including alcohol abuse active within the last 12 months)\n* Anyone with a history of intolerance or multiple adverse drug reactions or allergy to (es)citalopram.\n* Patients who are currently taking medications active on GABA, including benzodiazepines.","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Dan Iosifescu, MD","affiliation":"Depression Clinical and Research Program, Massachusetts General Hospital","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Depression Clinical and Research Program, Massachusetts General Hospital","city":"Boston","state":"Massachusetts","zip":"02114","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}}]},"referencesModule":{"seeAlsoLinks":[{"label":"Massachusetts General Hospital Depression Clinical and Research Program Website","url":"http://www.massgeneral.org/depression/"}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Escitalopram","description":"40 subjects met inclusion/exclusion criteria and started treatment with escitalopram"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"40"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"25"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"15"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Escitalopram","description":"40 subjects met inclusion/exclusion criteria and started study treatment"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"40"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"40"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"38.675","spread":"14.08"}]}]}]},{"title":"Gender","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"21"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"19"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"40"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Response and Remitter Status at Endpoint, Based on Change in Depression Severity Rating Scores","description":"The primary outcome in this study was based on the Hamilton Rating Scale for Depression, 17 items (HAMD-17). Clinical Response status was defined as \\> 50 % reduction in HAMD-17 scores from baseline to endpoint. Clinical Remitter status was defined as endpoint HAMD-17 score \\< 8.\n\n40 patients (21 female) with major depressive disorder (MDD) started the 12 week study treatment with escitalopram, 25 patients (15 female) completed the 12 weeks.","populationDescription":"40 patients (21 female) with MDD enrolled in the 12 week study, 25 patients (15 Female) completed. Current analyses are based on completers only.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"12 weeks","groups":[{"id":"OG000","title":"Open Label Escitalopram","description":"All subjects were treated with open label escitalopram"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"}]}],"classes":[{"title":"Clinical Response","categories":[{"measurements":[{"groupId":"OG000","value":"16"}]}]},{"title":"Clinical Remission","categories":[{"measurements":[{"groupId":"OG000","value":"14"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Adverse events were collected over 12 weeks of treatment.","eventGroups":[{"id":"EG000","title":"Escitalopram","description":"40 subjects met inclusion/exclusion criteria and started study treatment","seriousNumAffected":0,"seriousNumAtRisk":40,"otherNumAffected":20,"otherNumAtRisk":40}],"otherEvents":[{"term":"Insomnia","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":9,"numAffected":9,"numAtRisk":40}]},{"term":"GI Upset","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"GI upset category includes GI upset, nausea, diarrhea, Gas, stomach cramps, indigestion","stats":[{"groupId":"EG000","numEvents":8,"numAffected":8,"numAtRisk":40}]},{"term":"Fatigue/Sedation","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":40}]},{"term":"Headache","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":40}]},{"term":"Sexual Side Effects","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Sexual side effects included reports of general sexual side effects, decreased sex drive, anorgasmia, and erectile dysfunction.","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":40}]},{"term":"Jitteriness/Agitation","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":40}]},{"term":"Decreased Appetite","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":40}]},{"term":"Increased sweatiness","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":40}]},{"term":"Increased Appetite","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":40}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Dan Iosifescu","organization":"Massachusetts General Hospital","email":"diosifescu@partners.org"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003865","term":"Depressive Disorder, Major"},{"id":"D003863","term":"Depression"}],"ancestors":[{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"},{"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}