Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:46 AM
Study NCT ID:
NCT00316160
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2006-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sexual Functioning Study With Antidepressants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 347}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-24', 'studyFirstSubmitDate': '2006-04-18', 'studyFirstSubmitQcDate': '2006-04-18', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the effects of bupropion XL and venlafaxine XR on overall sexual functioning in outpatients with MDD as measured by mean changes in CSFQ-S total scores across Weeks 5, 6, 9 and 12.'}], 'secondaryOutcomes': [{'measure': 'Efficacy, Safety, Tolerability, Health Outcome'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sexual dysfunction', 'Depression', 'MDD'], 'conditions': ['Depressive Disorder, Major', 'Major Depressive Disorder (MDD)']}, 'referencesModule': {'references': [{'pmid': '16974189', 'type': 'RESULT', 'citation': 'Thase ME, Clayton AH, Haight BR, Thompson AH, Modell JG, Johnston JA. A double-blind comparison between bupropion XL and venlafaxine XR: sexual functioning, antidepressant efficacy, and tolerability. J Clin Psychopharmacol. 2006 Oct;26(5):482-8. doi: 10.1097/01.jcp.0000239790.83707.ab.'}]}, 'descriptionModule': {'briefSummary': 'Effects of two depression medication on sexual functioning', 'detailedDescription': 'A Twelve-week, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group, Active controlled, Escalating Dose Study to Compare the Effects on Sexual Functioning of Bupropion Hydrochloride Extended-release (WELLBUTRIN XL, 150-450 mg/day) and Extended-release Venlafaxine (EFFEXOR XR, 75-225 mg/day) in Subjects with Major Depressive Disorder'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Primary diagnosis of Major Depressive Disorder (MDD)\n* must have met DSM-IV criteria for current major depressive episode for at least 8 weeks but no long than 2 years.\n* HAM-D17 total score of \\>17 at screening and baseline.\n* Severity of illness score of \\>4 at screening and baseline.\n* Willing to discuss sexual functioning with investigator or designee.\n* Sexual activity that leads to orgasm at least every 2 weeks.\n\nExclusion Criteria:\n\n* Past or current DSM-IV diagnosis of Bipolar Disorder I or II, schizophrenia or another psychotic disorder(s).\n* Primary DSM-IV diagnosis or received treatment for Panic Disorder, Obsessive Compulsive Disorder or Post Stress Disorder within previous 12 months.\n* Poses a homicidal or serious suicidal risk, have made an attempt within months prior to screening or who has ever been homicidal.\n* Myocardial infarction with 1 year of screening.\n* Taken ibupropion hydrochloride or venlafaxine in the last 6 months.\n* Positive urine test for illicit drug use or alcohol or substance abuse within the past 12 months.\n* Psychotherapy within 3 months.\n* Pregnant.\n* Electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior of screening.\n* ECG or clinical evidence of atrial or ventricular hypertrophy.'}, 'identificationModule': {'nctId': 'NCT00316160', 'briefTitle': 'Sexual Functioning Study With Antidepressants', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Twelve-week, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group, Active Controlled, Escalating Dose Study to Compare the Effects on Sexual Functioning of Bupropion Hydrochloride Extended-release (WELLBUTRIN XL, 150-450 mg/Day) and Extended-release Venlafaxine (EFFEXOR XR, 75-225 mg/Day) in Subjects With Major Depressive Disorder', 'orgStudyIdInfo': {'id': '100368'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Bupropion Hydrochloride Extended-release', 'type': 'DRUG'}, {'name': 'Extended-release Venlafaxine', 'type': 'DRUG', 'otherNames': ['Bupropion Hydrochloride Extended-release']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85210', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 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