12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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A 12-Week Double-Blind, Placebo-Controlled, Flexible-Dose Trial of Pristiq® (Desvenlafaxine) Extended-Release Tablets in Generalized Social Anxiety Disorder

Conditions
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Social Anxiety Disorder

Intervention / Treatment
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* Drug: Pristiq
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pristiq<br>Flexible dose, 50-100mg QD | Drug: Pristiq<br>* Flexible dose, 50-100mg QD, for 12 weeks.<br>* Other names: desvenlafaxine;|
| Placebo Comparator: Placebo<br>Matching placebo | Drug: Placebo<br>* Matching placebo, taken QD for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score | Liebowitz Social Anxiety Scale, measuring social anxiety symptoms; possible total scores ranging from 0-144, with higher scores indicating greater severity of symptoms. | Baseline to study endpoint (Week 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression of Improvement Scale (CGI-I) | 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. | Baseline to Week 12 | 
| Patient Global Impression of Change | 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. | Baseline to study endpoint (Week 12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SAD, Social Anxiety Disorder, Social Phobia