Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT00182533
Status:
TERMINATED
Last Update Posted:
2018-03-22
First Post:
2005-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sertraline in Generalized Social Phobia With Co-Occurring Anxiety and Mood Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072861', 'term': 'Phobia, Social'}, {'id': 'D016584', 'term': 'Panic Disorder'}, {'id': 'D000379', 'term': 'Agoraphobia'}, {'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D019263', 'term': 'Dysthymic Disorder'}], 'ancestors': [{'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020280', 'term': 'Sertraline'}], 'ancestors': [{'id': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'whyStopped': 'Study drug could not be re-supplied', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-20', 'studyFirstSubmitDate': '2005-09-14', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Global Impression - Improvement ≤ 2', 'timeFrame': '16 weeks'}, {'measure': 'Liebowitz Social Anxiety Scale [LSAS] (mean change from baseline)', 'timeFrame': '16 weeks'}], 'secondaryOutcomes': [{'measure': 'Mean change from baseline on the following scales: Quality of Life and Employment Satisfaction Questionnaire', 'timeFrame': '16 weeks'}, {'measure': 'Sheehan Disability Scale', 'timeFrame': '16 weeks'}, {'measure': 'Social Phobia Scale', 'timeFrame': '16 weeks'}, {'measure': 'Brief Social Phobia Scale', 'timeFrame': '16 weeks'}, {'measure': 'Penn State Worry Questionnaire', 'timeFrame': '16 weeks'}, {'measure': 'Panic and Agoraphobia Scale', 'timeFrame': '16 weeks'}, {'measure': 'Davidson Trauma Scale', 'timeFrame': '16 weeks'}, {'measure': 'Social Anxiety Spectrum Self-Report (SHY-SR)', 'timeFrame': '16 weeks'}, {'measure': 'Yale-Brown Obsessive Compulsive Scale', 'timeFrame': '16 weeks'}, {'measure': 'Montgomery-Asberg Depression Rating Scale (MADRS)', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Generalized social phobia', 'Comorbid panic disorder with agoraphobia', 'Comorbid obsessive compulsive disorder', 'Comorbid generalized anxiety disorder', 'Comorbid major depressive disorder/Dysthymia'], 'conditions': ['Phobia, Social', 'Panic Disorder', 'Agoraphobia', 'Obsessive-Compulsive Disorder', 'Anxiety Disorders', 'Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'Selective serotonin reuptake inhibitors (SSRIs) including sertraline have been found to be effective in the treatment of generalized social phobia (GSP). However, virtually all of the current treatment studies with medicines, including the SSRIs, have excluded patients with social phobia who have other co-occurring conditions. In fact, 80% of individuals suffering with primary social phobia have at least one other anxiety. This study will evaluate the safety and efficacy of sertraline in the treatment of generalized social phobia with co-occurring anxiety and mood disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatient with primary Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) GSP plus at least one of the following comorbid DSM-IV anxiety disorders:\n\n * panic disorder with agoraphobia\n * obsessive compulsive disorder\n * major depressive disorder\n * generalized anxiety disorder\n* Score on LSAS \\> 50\n* Score on MADRS \\< 25\n\nExclusion Criteria:\n\n* Any other primary AXIS-I diagnosis\n* Criteria for alcohol/substance abuse/dependence\n* History (Hx) of bipolar disorder, schizophrenia or other psychotic disorder\n* A comorbid Axis II cluster A personality disorder\n* Current increased risk of concomitant suicide\n* Allergy/previous intolerance during an adequate trial (50mg/day for minimum of 4 weeks) of sertraline\n* Participation in any clinical trial 30 days prior to entering the study\n* Unable to tolerate being free of/shows signs of withdrawal from benzodiazepines for 4 weeks\n* Hx of seizures\n* Thyroid problems'}, 'identificationModule': {'nctId': 'NCT00182533', 'briefTitle': 'Sertraline in Generalized Social Phobia With Co-Occurring Anxiety and Mood Disorders', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Sertraline in the Treatment of Generalized Social Phobia With Comorbidity', 'orgStudyIdInfo': {'id': '02-195'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Sertraline', 'interventionNames': ['Drug: Sertraline']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sertraline', 'type': 'DRUG', 'otherNames': ['Zoloft'], 'description': '25 - 200 mg/day x 16 weeks', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '25 - 200 mg/day x 16 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8S 1B7', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'MacAnxiety Research Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Michael Van Ameringen, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hamilton Health Sciences Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}