Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT01316302
Status:
COMPLETED
Last Update Posted:
2016-10-17
First Post:
2011-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072861', 'term': 'Phobia, Social'}], 'ancestors': [{'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069468', 'term': 'Desvenlafaxine Succinate'}], 'ancestors': [{'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'MLiebowitz@MedicalResearchNetwork.com', 'phone': '(212) 595-5012', 'title': 'Michael R. Liebowitz, M.D.', 'organization': 'The Medical Research Network, LLC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '14 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Pristiq', 'description': 'Flexible dose, 50-100mg QD\n\nPristiq: Flexible dose, 50-100mg QD, for 12 weeks.', 'otherNumAtRisk': 30, 'otherNumAffected': 26, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Matching placebo\n\nPlacebo: Matching placebo, taken QD for 12 weeks.', 'otherNumAtRisk': 33, 'otherNumAffected': 25, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'dizziness/lightheadedness/feeling faint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea/queasiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 16, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'indigestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'flu/flu symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'soft stools/diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '.06'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pristiq', 'description': 'Flexible dose, 50-100mg QD\n\nPristiq: Flexible dose, 50-100mg QD, for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo\n\nPlacebo: Matching placebo, taken QD for 12 weeks.'}], 'classes': [{'title': 'Mean baseline LSAS total', 'categories': [{'measurements': [{'value': '93.4', 'spread': '17.1', 'groupId': 'OG000'}, {'value': '92.1', 'spread': '16.8', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint LSAS total', 'categories': [{'measurements': [{'value': '55.0', 'spread': '27.4', 'groupId': 'OG000'}, {'value': '63.4', 'spread': '22.1', 'groupId': 'OG001'}]}]}, {'title': 'Mean LSAS change from baseline', 'categories': [{'measurements': [{'value': '38.4', 'spread': '28.8', 'groupId': 'OG000'}, {'value': '28.7', 'spread': '24.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to study endpoint (Week 12)', 'description': 'Liebowitz Social Anxiety Scale, measuring social anxiety symptoms; possible total scores ranging from 0-144, with higher scores indicating greater severity of symptoms.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants for analysis was 29 subjects per arm; data analyzed at Week 12 or Last Observation Carried Forward for the 16 subjects who dropped out before completion. Five other randomized subjects (1 on drug, 4 on placebo) were excluded from the ITT sample because of insufficient data (n = 4) or poor compliance (n = 1).'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression of Improvement Scale (CGI-I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pristiq', 'description': 'Flexible dose, 50-100mg QD'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '48.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 12', 'description': 'CGI-I: one item, measuring overall improvement of illness; possible scores range from 1-7, with lower scores representing greater improvement. CGI-I responders: defined as having a CGI-I scores of 1 or 2 at Week 12/study endpoint.', 'unitOfMeasure': '% of subjects who were CGI-I responders', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pristiq', 'description': 'Flexible dose, 50-100mg QD'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '44.8', 'groupId': 'OG000'}, {'value': '40.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to study endpoint (Week 12)', 'description': 'Subject-rated global outcome scale. Subjects who rated themselves as 1 (Very Much Improved) or 2 (Much Improved) on the PGIC were considered self-rated responders.', 'unitOfMeasure': 'percentage of self-rated responders', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pristiq', 'description': 'Flexible dose, 50-100mg QD\n\nPristiq: Flexible dose, 50-100mg QD, for 12 weeks.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matching placebo\n\nPlacebo: Matching placebo, taken QD for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pristiq', 'description': 'Flexible dose, 50-100mg QD\n\nPristiq: Flexible dose, 50-100mg QD, for 12 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matching placebo\n\nPlacebo: Matching placebo, taken QD for 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.9', 'spread': '14.6', 'groupId': 'BG000'}, {'value': '41.9', 'spread': '13.7', 'groupId': 'BG001'}, {'value': '40.0', 'spread': '19.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-23', 'studyFirstSubmitDate': '2011-03-14', 'resultsFirstSubmitDate': '2014-09-30', 'studyFirstSubmitQcDate': '2011-03-14', 'lastUpdatePostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-06', 'studyFirstPostDateStruct': {'date': '2011-03-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score', 'timeFrame': 'Baseline to study endpoint (Week 12)', 'description': 'Liebowitz Social Anxiety Scale, measuring social anxiety symptoms; possible total scores ranging from 0-144, with higher scores indicating greater severity of symptoms.'}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impression of Improvement Scale (CGI-I)', 'timeFrame': 'Baseline to Week 12', 'description': 'CGI-I: one item, measuring overall improvement of illness; possible scores range from 1-7, with lower scores representing greater improvement. CGI-I responders: defined as having a CGI-I scores of 1 or 2 at Week 12/study endpoint.'}, {'measure': 'Patient Global Impression of Change', 'timeFrame': 'Baseline to study endpoint (Week 12)', 'description': 'Subject-rated global outcome scale. Subjects who rated themselves as 1 (Very Much Improved) or 2 (Much Improved) on the PGIC were considered self-rated responders.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Social Anxiety Disorder', 'Social Phobia', 'SAD'], 'conditions': ['Social Anxiety Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.MedicalResearchNetwork.com', 'label': 'Click here for more information about The Medical Research Network.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the efficacy and safety of Pristiq® in treatment of the symptoms of Generalized Social Anxiety Disorder (SAD).', 'detailedDescription': 'Social Anxiety Disorder (SAD) is recognized as a prevalent, chronic and disabling condition. Lifetime prevalence has been estimated at 13% in the National Comorbidity Survey. There is good reason to think that Pristiq® would be effective in Social Anxiety Disorder. Effexor XR, which is mechanistically similar to Pristiq®, was found effective for subjects with Generalized Social Anxiety Disorder in all five of the placebo controlled trials in which it was studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must give written informed consent prior to any study procedures.\n* Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Phobia/Social Anxiety Disorder, Generalized Subtype) according to DSM-IV-TR criteria, as determined by psychiatric evaluation with the Principal Investigator.\n* A minimum score of 60 on the LSAS total score at both Screening and Baseline visits.\n* A total HAM-D score of less than 15 at the Screening visit.\n* CGI Severity score of 4 or greater at both Screening and Baseline visits.\n* Female subjects of childbearing potential must commit to an effective form of contraception for the duration of the trial. Effective forms of contraception include: condoms with spermicide, diaphragm with spermicide, hormonal contraceptive agents (oral, transdermal, or injectable), and implantable contraceptive devices.\n\nExclusion Criteria:\n\n* An Axis I disorder other than SAD (e.g., post-traumatic stress disorder, obsessive compulsive disorder, panic disorder) within 24 weeks of the Baseline visit. Subjects with co-morbid MDD, GAD, dysthymia, or specific phobias will be allowed if GSAD is the primary disorder in terms of clinical severity, as determined by the investigator.\n* Any history or complication of schizophrenia or bipolar disorder.\n* Any complication of body dysmorphic disorder.\n* Substance dependence, as defined by DSM-IV-TR criteria, within 24 weeks of the Baseline visit.\n* Subjects who are currently pregnant, lactating, or of childbearing potential and not practicing an effective method of contraception.\n* Subjects scoring \\>2 on item #3 of the HAM-D, or who, in the opinion of the PI, are at a clinically significant risk for suicide.\n* Systolic blood pressure ≥165 and/or diastolic blood pressure ≥95.\n* Positive Urine Drug Screen at the Screening visit.\n* Any current unstable and/or clinically significant medical condition, based on history or as evidenced in Screening laboratory and ECG assessments.\n* Any history or complication of cancer or malignant tumor.\n* Fluoxetine within 28 days of Baseline\n* MAO inhibitors within 14 days of Baseline - Any other psychotropics (including SSRIs, SNRIs, and benzodiazepines) within 14 days of Baseline. Zolpidem (Ambien®) PRN is allowed for insomnia if not taken more than 3 times per week.\n* Subjects who started psychotherapy or cognitive-behavioral therapy within 24 weeks of the Baseline visit, except for supportive psychotherapy.\n* Electro-convulsive therapy (ECT) within 12 weeks of the Baseline visit.\n* Treatment refractory GSAD'}, 'identificationModule': {'nctId': 'NCT01316302', 'briefTitle': '12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder', 'organization': {'class': 'OTHER', 'fullName': 'The Medical Research Network'}, 'officialTitle': 'A 12-Week Double-Blind, Placebo-Controlled, Flexible-Dose Trial of Pristiq® (Desvenlafaxine) Extended-Release Tablets in Generalized Social Anxiety Disorder', 'orgStudyIdInfo': {'id': 'PF2010SAD'}, 'secondaryIdInfos': [{'id': 'WS1228302', 'type': 'OTHER_GRANT', 'domain': 'Pfizer, Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pristiq', 'description': 'Flexible dose, 50-100mg QD', 'interventionNames': ['Drug: Pristiq']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Pristiq', 'type': 'DRUG', 'otherNames': ['desvenlafaxine'], 'description': 'Flexible dose, 50-100mg QD, for 12 weeks.', 'armGroupLabels': ['Pristiq']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo, taken QD for 12 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10128', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'The Medical Research Network, LLC', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Michael R. Liebowitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Medical Research Network'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Medical Research Network', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}