12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder
- Registration Number
- NCT01316302
- Lead Sponsor
- The Medical Research Network
- Brief Summary
This study is designed to evaluate the efficacy and safety of Pristiq® in treatment of the symptoms of Generalized Social Anxiety Disorder (SAD).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
- Subjects must give written informed consent prior to any study procedures.
- 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.
- A minimum score of 60 on the LSAS total score at both Screening and Baseline visits.
- A total HAM-D score of less than 15 at the Screening visit.
- CGI Severity score of 4 or greater at both Screening and Baseline visits.
- 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.
- 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.
- Any history or complication of schizophrenia or bipolar disorder.
- Any complication of body dysmorphic disorder.
- Substance dependence, as defined by DSM-IV-TR criteria, within 24 weeks of the Baseline visit.
- Subjects who are currently pregnant, lactating, or of childbearing potential and not practicing an effective method of contraception.
- 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.
- Systolic blood pressure ≥165 and/or diastolic blood pressure ≥95.
- Positive Urine Drug Screen at the Screening visit.
- Any current unstable and/or clinically significant medical condition, based on history or as evidenced in Screening laboratory and ECG assessments.
- Any history or complication of cancer or malignant tumor.
- Fluoxetine within 28 days of Baseline
- 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.
- Subjects who started psychotherapy or cognitive-behavioral therapy within 24 weeks of the Baseline visit, except for supportive psychotherapy.
- Electro-convulsive therapy (ECT) within 12 weeks of the Baseline visit.
- Treatment refractory GSAD
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pristiq Pristiq Flexible dose, 50-100mg QD Placebo Placebo Matching placebo
- Primary Outcome Measures
Name Time Method Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score Baseline to study endpoint (Week 12) Liebowitz Social Anxiety Scale, measuring social anxiety symptoms; possible total scores ranging from 0-144, with higher scores indicating greater severity of symptoms.
- Secondary Outcome Measures
Name Time Method Patient Global Impression of Change Baseline to study endpoint (Week 12) 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.
Clinical Global Impression of Improvement Scale (CGI-I) Baseline to Week 12 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.
Trial Locations
- Locations (1)
The Medical Research Network, LLC
🇺🇸New York, New York, United States