Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-27 @ 4:12 AM
Study NCT ID:
NCT00051259
Status:
COMPLETED
Last Update Posted:
2010-10-04
First Post:
2003-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Antidepressants on Sexual Functioning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}], '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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-01', 'studyFirstSubmitDate': '2003-01-07', 'studyFirstSubmitQcDate': '2003-01-07', 'lastUpdatePostDateStruct': {'date': '2010-10-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of subjects with orgasm dysfunction. Change in HAMD-17 total score.'}], 'secondaryOutcomes': [{'measure': 'Percent of subjects in remission, HAMD-17. Changes in Sexual Functioning Questionnaire. Percent of responders, HAMD-17 CGI-I and CGI-S.'}]}, 'conditionsModule': {'keywords': ['depression', 'MDD', 'sexual dysfunction', 'orgasm disorder'], 'conditions': ['Major Depressive Disorder (MDD)']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to study the effects of two depression medications on sexual functioning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary diagnosis of Major Depressive Disorder (MDD) with current duration lasting 12 weeks but no greater than 2 years.\n* Subjects must engage in sexual activity that leads to orgasm at least once every two weeks.\n* Subject must have normal orgasmic function and be willing to discuss with investigator.\n\nExclusion Criteria:\n\n* Subjects that have arousal or orgasm dysfunction.\n* Has previously failed to respond to two adequate trials of antidepressants in past 2 years.\n* Subject has other unstable medical disorders.\n* Subject has a positive urine test for illicit drug use at screening.'}, 'identificationModule': {'nctId': 'NCT00051259', 'briefTitle': 'Effects of Antidepressants on Sexual Functioning', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Effects on Sexual Functioning of Extended-Release Bupropion Hydrochloride (300-450mg) and Escitalopram (10-20mg) in Outpatients With Moderate to Severe Major Depression Over an Eight-Week Treatment Period', 'orgStudyIdInfo': {'id': 'AK130926'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Extended-Release Bupropion Hydrochloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94709', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, 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'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'GSK'}}}}