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

NCT ID: NCT01316302

Last Updated: 2016-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-12-31

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.

Conditions

Social Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Pristiq

Flexible dose, 50-100mg QD

Group Type: EXPERIMENTAL

Pristiq

Intervention Type: DRUG

Flexible dose, 50-100mg QD, for 12 weeks.

Placebo

Matching placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo, taken QD for 12 weeks.

Interventions

Pristiq

Flexible dose, 50-100mg QD, for 12 weeks.

Intervention Type: DRUG

Placebo

Matching placebo, taken QD for 12 weeks.

Intervention Type: DRUG

Other Intervention Names

desvenlafaxine

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

The Medical Research Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael R. Liebowitz, MD

Role: PRINCIPAL_INVESTIGATOR

The Medical Research Network

Locations

The Medical Research Network, LLC

New York, New York, United States

Countries

United States

Related Links

http://www.MedicalResearchNetwork.com

Click here for more information about The Medical Research Network.

Other Identifiers

WS1228302

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PF2010SAD

Identifier Type: -

Identifier Source: org_study_id