{"protocolSection":{"identificationModule":{"nctId":"NCT01316302","orgStudyIdInfo":{"id":"PF2010SAD"},"secondaryIdInfos":[{"id":"WS1228302","type":"OTHER_GRANT","domain":"Pfizer, Inc."}],"organization":{"fullName":"The Medical Research Network","class":"OTHER"},"briefTitle":"12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder","officialTitle":"A 12-Week Double-Blind, Placebo-Controlled, Flexible-Dose Trial of Pristiq® (Desvenlafaxine) Extended-Release Tablets in Generalized Social Anxiety Disorder"},"statusModule":{"statusVerifiedDate":"2016-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2011-04"},"primaryCompletionDateStruct":{"date":"2012-11","type":"ACTUAL"},"completionDateStruct":{"date":"2012-12","type":"ACTUAL"},"studyFirstSubmitDate":"2011-03-14","studyFirstSubmitQcDate":"2011-03-14","studyFirstPostDateStruct":{"date":"2011-03-16","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-09-30","resultsFirstSubmitQcDate":"2014-10-06","resultsFirstPostDateStruct":{"date":"2014-10-08","type":"ESTIMATED"},"lastUpdateSubmitDate":"2016-08-23","lastUpdatePostDateStruct":{"date":"2016-10-17","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"The Medical Research Network","class":"OTHER"},"collaborators":[{"name":"Pfizer","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"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."},"conditionsModule":{"conditions":["Social Anxiety Disorder"],"keywords":["Social Anxiety Disorder","Social Phobia","SAD"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":63,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Pristiq","type":"EXPERIMENTAL","description":"Flexible dose, 50-100mg QD","interventionNames":["Drug: Pristiq"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Matching placebo","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Pristiq","description":"Flexible dose, 50-100mg QD, for 12 weeks.","armGroupLabels":["Pristiq"],"otherNames":["desvenlafaxine"]},{"type":"DRUG","name":"Placebo","description":"Matching placebo, taken QD for 12 weeks.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score","description":"Liebowitz Social Anxiety Scale, measuring social anxiety symptoms; possible total scores ranging from 0-144, with higher scores indicating greater severity of symptoms.","timeFrame":"Baseline to study endpoint (Week 12)"}],"secondaryOutcomes":[{"measure":"Clinical Global Impression of Improvement Scale (CGI-I)","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.","timeFrame":"Baseline to Week 12"},{"measure":"Patient Global Impression of Change","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.","timeFrame":"Baseline to study endpoint (Week 12)"}]},"eligibilityModule":{"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","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Michael R. Liebowitz, MD","affiliation":"The Medical Research Network","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"The Medical Research Network, LLC","city":"New York","state":"New York","zip":"10128","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}}]},"referencesModule":{"seeAlsoLinks":[{"label":"Click here for more information about The Medical Research Network.","url":"http://www.MedicalResearchNetwork.com"}]}},"resultsSection":{"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":{"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"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"33"},{"groupId":"BG002","value":"63"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"39.9","spread":"14.6"},{"groupId":"BG001","value":"41.9","spread":"13.7"},{"groupId":"BG002","value":"40.0","spread":"19.9"}]}]}]},{"title":"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":"30"},{"groupId":"BG001","value":"33"},{"groupId":"BG002","value":"63"}]},{"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":"16"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"29"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"34"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"33"},{"groupId":"BG002","value":"63"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score","description":"Liebowitz Social Anxiety Scale, measuring social anxiety symptoms; possible total scores ranging from 0-144, with higher scores indicating greater severity of symptoms.","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).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Scores on a scale","timeFrame":"Baseline to study endpoint (Week 12)","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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"29"}]}],"classes":[{"title":"Mean baseline LSAS total","categories":[{"measurements":[{"groupId":"OG000","value":"93.4","spread":"17.1"},{"groupId":"OG001","value":"92.1","spread":"16.8"}]}]},{"title":"Endpoint LSAS total","categories":[{"measurements":[{"groupId":"OG000","value":"55.0","spread":"27.4"},{"groupId":"OG001","value":"63.4","spread":"22.1"}]}]},{"title":"Mean LSAS change from baseline","categories":[{"measurements":[{"groupId":"OG000","value":"38.4","spread":"28.8"},{"groupId":"OG001","value":"28.7","spread":"24.2"}]}]}]},{"type":"SECONDARY","title":"Clinical Global Impression of Improvement Scale (CGI-I)","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.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"% of subjects who were CGI-I responders","timeFrame":"Baseline to Week 12","groups":[{"id":"OG000","title":"Pristiq","description":"Flexible dose, 50-100mg QD"},{"id":"OG001","title":"Placebo","description":"Matching placebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"29"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"48.3"}]}]}]},{"type":"SECONDARY","title":"Patient Global Impression of Change","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.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of self-rated responders","timeFrame":"Baseline to study endpoint (Week 12)","groups":[{"id":"OG000","title":"Pristiq","description":"Flexible dose, 50-100mg QD"},{"id":"OG001","title":"Placebo","description":"Matching placebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"29"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"44.8"},{"groupId":"OG001","value":"40.7"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":".06","timeFrame":"14 weeks","eventGroups":[{"id":"EG000","title":"Pristiq","description":"Flexible dose, 50-100mg QD\n\nPristiq: Flexible dose, 50-100mg QD, for 12 weeks.","seriousNumAffected":0,"seriousNumAtRisk":30,"otherNumAffected":26,"otherNumAtRisk":30},{"id":"EG001","title":"Placebo","description":"Matching placebo\n\nPlacebo: Matching placebo, taken QD for 12 weeks.","seriousNumAffected":0,"seriousNumAtRisk":33,"otherNumAffected":25,"otherNumAtRisk":33}],"otherEvents":[{"term":"dizziness/lightheadedness/feeling faint","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":12,"numAffected":11,"numAtRisk":30},{"groupId":"EG001","numEvents":6,"numAffected":4,"numAtRisk":33}]},{"term":"nausea/queasiness","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":16,"numAffected":11,"numAtRisk":30},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":33}]},{"term":"drowsiness","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":9,"numAffected":7,"numAtRisk":30},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":33}]},{"term":"insomnia","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":8,"numAffected":5,"numAtRisk":30},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":33}]},{"term":"headache","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":6,"numAffected":4,"numAtRisk":30},{"groupId":"EG001","numEvents":6,"numAffected":5,"numAtRisk":33}]},{"term":"fatigue","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":30},{"groupId":"EG001","numEvents":5,"numAffected":4,"numAtRisk":33}]},{"term":"decreased appetite","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":7,"numAffected":6,"numAtRisk":30},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":33}]},{"term":"indigestion","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":30},{"groupId":"EG001","numEvents":2,"numAffected":1,"numAtRisk":33}]},{"term":"flu/flu symptoms","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":30},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":33}]},{"term":"soft stools/diarrhea","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":33}]},{"term":"dry mouth","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":30},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":33}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Michael R. Liebowitz, M.D.","organization":"The Medical Research Network, LLC","email":"MLiebowitz@MedicalResearchNetwork.com","phone":"(212) 595-5012"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"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"}]}},"hasResults":true}