{"protocolSection":{"identificationModule":{"nctId":"NCT00166114","orgStudyIdInfo":{"id":"0473-2002"},"secondaryIdInfos":[{"id":"1R01HL065523-01A2","type":"NIH","link":"https://reporter.nih.gov/quickSearch/1R01HL065523-01A2"}],"organization":{"fullName":"Emory University","class":"OTHER"},"briefTitle":"Depression, Epinephrine, and Platelet Function","officialTitle":"Do Antidepressants Reverse the Effects of Early Life Stress on the Brain and Thrombovascular System and Improve Psychological, Neuroendocrine, and Platelet Function: A Study of Men and Women With Childhood Abuse."},"statusModule":{"statusVerifiedDate":"2015-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2002-02"},"primaryCompletionDateStruct":{"date":"2009-01","type":"ACTUAL"},"completionDateStruct":{"date":"2009-01","type":"ACTUAL"},"studyFirstSubmitDate":"2005-09-13","studyFirstSubmitQcDate":"2005-09-13","studyFirstPostDateStruct":{"date":"2005-09-14","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-12-09","resultsFirstSubmitQcDate":"2015-07-15","resultsFirstPostDateStruct":{"date":"2015-07-23","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-07-15","lastUpdatePostDateStruct":{"date":"2015-07-23","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Dominique Musselman","investigatorTitle":"Associate Professor","investigatorAffiliation":"Emory University"},"leadSponsor":{"name":"Emory University","class":"OTHER"},"collaborators":[{"name":"National Heart, Lung, and Blood Institute (NHLBI)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"Men and women who have suffered sexual and/or physical abuse before the age of 12 are at increased risk for anxiety and mood disorders, other serious psychiatric disorders, and likely medical illnesses. What is not known is whether adult survivors of childhood adversity experience heightened negative emotions and increased physical responses due to altered norepinephrine or serotonin systems in their brains and bodies. The investigators expect to see that survivors of childhood adversity experience heightened negative emotions and increased physical responses to stress."},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["platelet function","childhood abuse","depression","antidepressants","immune function","stress response"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":40,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Escitalopram","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: Escitalopram"]},{"label":"Desipramine","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: Desipramine"]}],"interventions":[{"type":"DRUG","name":"Escitalopram","description":"10 mg of Escitalopram, and titrated up to 20 mg of Escitalopram after day 22 of intervention","armGroupLabels":["Escitalopram"],"otherNames":["Lexapro"]},{"type":"DRUG","name":"Desipramine","description":"25 mg of Desipramine for day 1-3, 50 mg of Desipramine for day 4-7, 75 mg of Desipramine for day 8-14, 100 mg of Desipramine for day 15-21. Titrated between 125 mg to 200 mg of Desipramine for day 22-56 of intervention","armGroupLabels":["Desipramine"],"otherNames":["Norpramin"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week8","description":"Number of subjects that showed no response, partial response, and response based on scores from baseline and week 8.\n\nThe 21-item HDRS measures depression severity. The scoring is sum the total of all 21 items to arrive at the total score, with a range of 0 to 60, where higher scores indicated greater severity. Nine items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Eleven items are scored from 0 - 2 (0 = absent and 2 = severe). The last item is scored on a 4-point scale of 0-3 (0 = absent and 3 = severe). The HDRS at week 8 was compared to the baseline HDRS and each participant's response was calculated using the below table:\n\nNo Response = \\< 25% change in Depression Rating Scale Score Partial Responder = \\< 50% to \\>25% change in Depression Rating Scale Score Responder = 50% or greater change in Depression Rating Scale Score","timeFrame":"Baseline, Week 8"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n* Individuals who are suicidal, psychotic, or with bipolar depression\n* alcohol or substance abuse or\n* regularly use medications which alter mood or blood vessel function (zolpidem or zalpelon, aspirin, nonsteroidal antiinflammatory drugs, sympatholytics, theophylline, central acting agonists, beta-blockers, coumadin, nitrates, triazolobenzodiazapines, or use steroids (testosterone-patch or pill form), use tryptophan or monoamine oxidase inhibitors (MAOIs),\n* have narrow-angle glaucoma, liver disease,\n* severe allergies (especially to antidepressants similar to escitalopram or desipramine)\n* seizures, or a serious medical disorder (e.g. hypothyroidism) that is unstable or is untreated.\n* Depressed patients with a prior history of severe adverse events associated with SSRIs or TCAs will not be accepted into the study.","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"55 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Dominique L Musselman, MD,MS","affiliation":"Emory University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Emory University School of Medicine","city":"Atlanta","state":"Georgia","zip":"30322","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}}]},"referencesModule":{"references":[{"pmid":"22966422","type":"BACKGROUND","citation":"Royster EB, Trimble LM, Cotsonis G, Schmotzer B, Manatunga A, Rushing NN, Pagnoni G, Auyeung SF, Brown AR, Schoenbeck J, Murthy S, McDonald WM, Musselman DL. Changes in heart rate variability of depressed patients after electroconvulsive therapy. Cardiovasc Psychiatry Neurol. 2012;2012:794043. doi: 10.1155/2012/794043. Epub 2012 Aug 27."},{"pmid":"18619999","type":"BACKGROUND","citation":"Shively CA, Musselman DL, Willard SL. Stress, depression, and coronary artery disease: modeling comorbidity in female primates. Neurosci Biobehav Rev. 2009 Feb;33(2):133-44. doi: 10.1016/j.neubiorev.2008.06.006. Epub 2008 Jun 24."},{"pmid":"15953798","type":"BACKGROUND","citation":"Bruce EC, Musselman DL. Depression, alterations in platelet function, and ischemic heart disease. Psychosom Med. 2005 May-Jun;67 Suppl 1:S34-6. doi: 10.1097/01.psy.0000164227.63647.d9."},{"pmid":"18378867","type":"RESULT","citation":"Bruce EC, Guo Y, Lawson KC, Manatunga AK, Auyeung SF, McDonald WM, Rushing N, Brown AR, Gilles N, Emery M, Bonsall R, Porquez J, Stowe Z, Nemeroff CB, Musselman DL. Platelet thromboxane A2 secretion in patients with major depression responsive to electroconvulsive therapy. Psychosom Med. 2008 Apr;70(3):319-27. doi: 10.1097/PSY.0b013e3181663580. Epub 2008 Mar 31."}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"Subjects recruited from Emory Psychiatry Clinic outpatient population","groups":[{"id":"FG000","title":"Escitalopram","description":"Subjects received 10 mg of Escitalopram for 22 days and then were titrated up to 20 mg of Escitalopram after day 22 of intervention until day 56"},{"id":"FG001","title":"Desipramine","description":"Subjects received 25 mg of desipramine for day 1-3, 50 mg of desipramine for day 4-7, 75 mg of desipramine for day 8-14, 100 mg of desipramine for day 15-21. Subjects titrated between 125 mg to 200 mg of desipramine for day 22-56 of intervention"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"19"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"13"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"6"}]}],"dropWithdraws":[{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Escitalopram","description":"Subjects received 10 mg of Escitalopram for 22 days and then were titrated up to 20 mg of Escitalopram after day 22 until day 56"},{"id":"BG001","title":"Desipramine","description":"Subjects received 25 mg of desipramine for day 1-3, 50 mg of desipramine for day 4-7, 75 mg of desipramine for day 8-14, 100 mg of desipramine for day 15-21. Subjects titrated between 125 mg to 200 mg of desipramine for day 22-56 of intervention"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"19"},{"groupId":"BG002","value":"40"}]}],"measures":[{"title":"Age, Categorical","description":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"19"},{"groupId":"BG002","value":"40"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"14"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"26"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"19"},{"groupId":"BG002","value":"40"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week8","description":"Number of subjects that showed no response, partial response, and response based on scores from baseline and week 8.\n\nThe 21-item HDRS measures depression severity. The scoring is sum the total of all 21 items to arrive at the total score, with a range of 0 to 60, where higher scores indicated greater severity. Nine items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Eleven items are scored from 0 - 2 (0 = absent and 2 = severe). The last item is scored on a 4-point scale of 0-3 (0 = absent and 3 = severe). The HDRS at week 8 was compared to the baseline HDRS and each participant's response was calculated using the below table:\n\nNo Response = \\< 25% change in Depression Rating Scale Score Partial Responder = \\< 50% to \\>25% change in Depression Rating Scale Score Responder = 50% or greater change in Depression Rating Scale Score","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline, Week 8","groups":[{"id":"OG000","title":"Escitalopram","description":"Subjects received 10 mg of Escitalopram for 22 days and then were titrated up to 20 mg of Escitalopram after day 22 of intervention until day 56"},{"id":"OG001","title":"Desipramine","description":"Subjects received 25 mg of desipramine for day 1-3, 50 mg of desipramine for day 4-7, 75 mg of desipramine for day 8-14, 100 mg of desipramine for day 15-21. Subjects titrated between 125 mg to 200 mg of desipramine for day 22-56 of intervention"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"13"}]}],"classes":[{"title":"Response","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"9"}]}]},{"title":"No or Partial Response","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"Chi Square test was performed comparing actual vs. expected non- and partial response or response to either escitalopram or desipramine treatment.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":".918","statisticalMethod":"Chi-squared"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","eventGroups":[{"id":"EG000","title":"Escitalopram","description":"10 mg of Escitalopram, and titrated up to 20 mg of Escitalopram after day 22 of intervention","seriousNumAffected":1,"seriousNumAtRisk":21,"otherNumAffected":13,"otherNumAtRisk":21},{"id":"EG001","title":"Desipramine","description":"25 mg of Desipramine for day 1-3, 50 mg of Desipramine for day 4-7, 75 mg of Desipramine for day 8-14, 100 mg of Desipramine for day 15-21. Titrated between 125 mg to 200 mg of Desipramine for day 22-56 of intervention","seriousNumAffected":0,"seriousNumAtRisk":19,"otherNumAffected":18,"otherNumAtRisk":19}],"seriousEvents":[{"term":"Suicide gesture (superficial lacerations to wrists with a razor)","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21},{"groupId":"EG001","numAffected":0,"numAtRisk":19}]}],"otherEvents":[{"term":"Dry Mouth","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21},{"groupId":"EG001","numAffected":2,"numAtRisk":19}]},{"term":"Orthostatic Tachycardia","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21},{"groupId":"EG001","numAffected":1,"numAtRisk":19}]},{"term":"Rash","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21},{"groupId":"EG001","numAffected":1,"numAtRisk":19}]},{"term":"Pruritis","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21},{"groupId":"EG001","numAffected":1,"numAtRisk":19}]},{"term":"Heartburn","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21},{"groupId":"EG001","numAffected":0,"numAtRisk":19}]},{"term":"Headache","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21},{"groupId":"EG001","numAffected":3,"numAtRisk":19}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21},{"groupId":"EG001","numAffected":2,"numAtRisk":19}]},{"term":"Stomach Pain","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21},{"groupId":"EG001","numAffected":1,"numAtRisk":19}]},{"term":"Indigestion","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21},{"groupId":"EG001","numAffected":1,"numAtRisk":19}]},{"term":"Increased Liver Function Test","organSystem":"Metabolism and nutrition disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21},{"groupId":"EG001","numAffected":1,"numAtRisk":19}]},{"term":"Upper Respiratory Infection","organSystem":"Infections and infestations","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21},{"groupId":"EG001","numAffected":1,"numAtRisk":19}]},{"term":"Sedation","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21},{"groupId":"EG001","numAffected":0,"numAtRisk":19}]},{"term":"Fatigue","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21},{"groupId":"EG001","numAffected":0,"numAtRisk":19}]},{"term":"Insomnia","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21},{"groupId":"EG001","numAffected":1,"numAtRisk":19}]},{"term":"Weight Loss","organSystem":"Metabolism and nutrition disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21},{"groupId":"EG001","numAffected":1,"numAtRisk":19}]},{"term":"Confusion","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21},{"groupId":"EG001","numAffected":0,"numAtRisk":19}]},{"term":"Irritability","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21},{"groupId":"EG001","numAffected":0,"numAtRisk":19}]},{"term":"Ejaculation Disorder","organSystem":"Reproductive system and breast disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21},{"groupId":"EG001","numAffected":1,"numAtRisk":19}]},{"term":"Pregnancy","organSystem":"Pregnancy, puerperium and perinatal conditions","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21},{"groupId":"EG001","numAffected":1,"numAtRisk":19}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dominique Musselman, MD, MSCR","organization":"University of Miami School of Medicine","email":"dmusselman@med.miami.edu","phone":"404-723-8361"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003865","term":"Depressive Disorder, Major"},{"id":"D003863","term":"Depression"},{"id":"D015775","term":"Fractures, Stress"}],"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"},{"id":"D050723","term":"Fractures, Bone"},{"id":"D014947","term":"Wounds and Injuries"}]},"interventionBrowseModule":{"meshes":[{"id":"D000089983","term":"Escitalopram"},{"id":"D003891","term":"Desipramine"}],"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"},{"id":"D003984","term":"Dibenzazepines"},{"id":"D006575","term":"Heterocyclic Compounds, 3-Ring"}]}},"hasResults":true}