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

Social Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01316302
• Other study ID #: PF2010SAD
• Secondary ID: WS1228302
• Status: Completed
• Phase: Phase 4
• First received: March 14, 2011
• Last updated: October 6, 2014
• Start date: April 2011
• Est. completion date: December 2012

Study information

• Verified date: October 2014
• Source: The Medical Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the efficacy and safety of Pristiq® in treatment of the symptoms of Generalized Social Anxiety Disorder (SAD).

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 information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobic Disorders
• Social Anxiety Disorder

Intervention

Drug:
• Pristiq
Flexible dose, 50-100mg QD, for 12 weeks.
• Placebo
Matching placebo, taken QD for 12 weeks.

Locations

Country	Name	City	State
United States	The Medical Research Network, LLC	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
The Medical Research Network	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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	No
Secondary	Clinical Global Impression of Severity Scale (CGI-S)	Clinical Global Impression of Severity scale: one item, measuring overall severity of illness; possible scores range from 1-7, with higher scores representing greater severity of illness.	Baseline to Week 12	No
Secondary	Change on the LSAS Anxiety and Avoidance Subscales		Baseline to Week 12	No

External Links

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