Clinical trial NCT01316302: 12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder
Official title: A 12-Week Double-Blind, Placebo-Controlled, Flexible-Dose Trial of Pristiq® (Desvenlafaxine) Extended-Release Tablets in Generalized Social Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Social Anxiety Disorder
Keywords: Social Anxiety Disorder
Social Phobia
SAD
Lead sponsor: The Medical Research Network
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2011-03-16
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score
timeFrame: Baseline to study endpoint (Week 12)
Secondary outcomes:
measure: Clinical Global Impression of Improvement Scale (CGI-I)
timeFrame: Baseline to Week 12
measure: Patient Global Impression of Change
timeFrame: Baseline to study endpoint (Week 12)
Other outcomes:
Locations:
city: New York
country: United States
facility: The Medical Research Network, LLC
state: New York
Study officials:
affiliation: The Medical Research Network
name: Michael R. Liebowitz, MD
role: PRINCIPAL_INVESTIGATOR
References: