{"protocolSection":{"identificationModule":{"nctId":"NCT00833469","orgStudyIdInfo":{"id":"2008-P-001509"},"organization":{"fullName":"Massachusetts General Hospital","class":"OTHER"},"briefTitle":"Escitalopram (Lexapro) for the Treatment of Postpartum Depression","officialTitle":"Escitalopram for the Treatment of Postpartum Depression","acronym":"LexaproPPD"},"statusModule":{"statusVerifiedDate":"2014-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-01"},"primaryCompletionDateStruct":{"date":"2011-04","type":"ACTUAL"},"completionDateStruct":{"date":"2011-04","type":"ACTUAL"},"studyFirstSubmitDate":"2009-01-29","studyFirstSubmitQcDate":"2009-01-30","studyFirstPostDateStruct":{"date":"2009-02-02","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-07-11","resultsFirstSubmitQcDate":"2014-08-05","resultsFirstPostDateStruct":{"date":"2014-08-06","type":"ESTIMATED"},"lastUpdateSubmitDate":"2014-08-05","lastUpdatePostDateStruct":{"date":"2014-08-06","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Marlene P. Freeman, MD","investigatorTitle":"Clinical Director, Center for Women's Mental Health","investigatorAffiliation":"Massachusetts General Hospital"},"leadSponsor":{"name":"Massachusetts General Hospital","class":"OTHER"},"collaborators":[{"name":"Forest Laboratories","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to determine whether women with postpartum major depressive disorder (MDD) will experience a significant decrease in depressive symptoms from baseline over an eight-week treatment intervention with escitalopram (Lexapro). Also, to determine whether women with postpartum MDD will experience a significant decrease in anxiety symptoms."},"conditionsModule":{"conditions":["Postpartum Depression"],"keywords":["women","postpartum depression","anxiety"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":7,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Escitalopram","type":"EXPERIMENTAL","description":"Flexible dose escitalopram 10mg","interventionNames":["Drug: Escitalopram"]}],"interventions":[{"type":"DRUG","name":"Escitalopram","description":"Once daily by mouth","armGroupLabels":["Escitalopram"],"otherNames":["Lexapro"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS)","description":"The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms (range 0-60, higher score indicates greater symptom burden).","timeFrame":"8 weeks"}],"secondaryOutcomes":[{"measure":"Change in Edinburgh Postnatal Depression Scale (EPDS)","description":"The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression (range 0-30, higher score indicates greater symptom burden). A score of \\>9 is indicative of perinatal major depression.","timeFrame":"8 weeks"},{"measure":"Change in Beck Anxiety Inventory (BAI)","description":"Beck Anxiety Inventory (BAI): The BAI is a 21-item self-report questionnaire measuring typical symptoms of anxiety during the past week (range 0-63, higher score indicates greater anxiety).","timeFrame":"8 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Women ages 18 to 45 years old\n* Subjects must meet criteria for a major depressive episode with symptoms developing within three month of live childbirth\n* Subjects must present within six months of childbirth\n* MADRS score \\>15\n* BAI score \\>10\n* Subjects will be able to be treated on an outpatient basis\n* Subjects will be able to provide written informed consent\n\nExclusion Criteria:\n\n* Subjects who have taken any psychotropic medication, including antidepressants and anti-anxiety medication, within the past two weeks (with the exception of non-benzodiazepine medications used for sleep, including trazodone, zolpidem, eszopiclone, etc)\n* Suicidal ideation with active plan or intent, as determined by the investigator\n* Presence of psychotic symptoms or homicidal ideation\n* History of mania or hypomania\n* Pregnant or breastfeeding\n* Presence of chronic depression or dysthymia, or chronic or treatment resistant anxiety disorders, as determined by investigator\n* Active alcohol/substance abuse currently or within the past year\n* Abnormal TSH, severe anemia, or uncontrolled hypertension","healthyVolunteers":false,"sex":"FEMALE","minimumAge":"18 Years","maximumAge":"45 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Marlene P Freeman, MD","affiliation":"Massachusetts General Hospital","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","zip":"02114","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}}]},"referencesModule":{"seeAlsoLinks":[{"label":"Center for Women's Mental Health Online Resource","url":"http://www.womensmentalhealth.org"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Seven subjects were enrolled in this study. Prior to receiving treatment, two subjects were found to be ineligible per protocol eligibility requirements.","groups":[{"id":"FG000","title":"Escitalopram","description":"Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion)."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"5"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Of the 7 subjects consented, 5 were eligible to initiate study intervention. Out of these 5, 1 subject dropped prior to V1 and no baseline information is available for her.","groups":[{"id":"BG000","title":"Escitalopram","description":"Flexible dose escitalopram 10mg\n\nEscitalopram: Once daily by mouth"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"4"}]}],"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":"4"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"4"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"3"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"1"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"3"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"4"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS)","description":"The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms (range 0-60, higher score indicates greater symptom burden).","populationDescription":"Of 7 subjects consented, 5 were eligible after V1. Before V2, 1 subject dropped and 1 was LTF. Three subjects completed the study.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"Escitalopram","description":"Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-21.33","spread":"11.24"}]}]}]},{"type":"SECONDARY","title":"Change in Edinburgh Postnatal Depression Scale (EPDS)","description":"The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression (range 0-30, higher score indicates greater symptom burden). A score of \\>9 is indicative of perinatal major depression.","populationDescription":"Of 7 subjects consented, 5 were eligible after V1. Before V2, 1 subject dropped and 1 was LTF. Three subjects completed the study.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"Escitalopram","description":"Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-19.33","spread":"2.52"}]}]}]},{"type":"SECONDARY","title":"Change in Beck Anxiety Inventory (BAI)","description":"Beck Anxiety Inventory (BAI): The BAI is a 21-item self-report questionnaire measuring typical symptoms of anxiety during the past week (range 0-63, higher score indicates greater anxiety).","populationDescription":"Of 7 subjects consented, 5 were eligible after V1. Before V2, 1 subject dropped and 1 was LTF. Three subjects completed the study.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"Escitalopram","description":"Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-15.00","spread":"9.85"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"32 months","eventGroups":[{"id":"EG000","title":"Escitalopram","description":"Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).","seriousNumAffected":0,"seriousNumAtRisk":3,"otherNumAffected":3,"otherNumAtRisk":3}],"otherEvents":[{"term":"Nausea","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3}]},{"term":"Decreased sleep","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3}]},{"term":"Jaw tightness","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3}]},{"term":"Dry skin","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3}]},{"term":"Vaginal discharge","organSystem":"Reproductive system and breast disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"We recruited only 7 patients out of a projected 20. Patients were not referred because they were breastfeeding or preferred to receive treatment from their primary care doctor. We also suspect that many women with PPD do not seek treatment at all."},"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Marlene Freeman, MD","organization":"Massachusetts General Hospital","email":"mfreeman@partners.org","phone":"617-643-6403"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D019052","term":"Depression, Postpartum"},{"id":"D001008","term":"Anxiety Disorders"}],"ancestors":[{"id":"D011644","term":"Puerperal Disorders"},{"id":"D011248","term":"Pregnancy Complications"},{"id":"D005261","term":"Female Urogenital Diseases and Pregnancy Complications"},{"id":"D000091642","term":"Urogenital Diseases"},{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"}]},"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}