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

The Medical Research Network

Status and phase

Completed

Phase 4

Conditions

Social Anxiety Disorder

Treatments

Drug: Pristiq

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01316302

WS1228302 (Other Grant/Funding Number)

PF2010SAD

Details and patient eligibility

About

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

Full 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.

Enrollment

63 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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