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

Information source: The Medical Research Network
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Social Anxiety Disorder

Intervention: Pristiq (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: The Medical Research Network

Official(s) and/or principal investigator(s):
Michael R. Liebowitz, MD, Principal Investigator, Affiliation: The Medical Research Network


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

Clinical Details

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

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

Primary outcome: Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score

Secondary outcome:

Clinical Global Impression of Improvement Scale (CGI-I)

Clinical Global Impression of Severity Scale (CGI-S)

Change on the LSAS Anxiety and Avoidance Subscales

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.


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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

Locations and Contacts

The Medical Research Network, LLC, New York, New York 10128, United States
Additional Information

Click here for more information about The Medical Research Network.

Starting date: April 2011
Last updated: October 6, 2014

Page last updated: August 23, 2015

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