Geodon for the Treatment of Refractory Social Anxiety Disorder

Social Anxiety Disorder Clinical Trial

— SAD  

Official title:

Ziprasidone for the Treatment of Refractory Social Anxiety Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00215150
• Other study ID #: Pro00012882
• Secondary ID: 6479
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2005
• Last updated: October 23, 2014
• Start date: November 2004
• Est. completion date: July 2009

Study information

• Verified date: April 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the effectiveness and tolerability of augmentation treatment of ziprasidone to achieve remission among patients with social anxiety disorder (SAD) who did not remit on sertraline treatment alone

Description:

This is a two-phase study consisting of 8 weeks of open label treatment with sertraline (50-200 mg/day) in patients with SAD and in those who fail to demonstrate symptom remission on sertraline alone, 8 weeks of randomized, double-blind, placebo-controlled augmentation with ziprasidone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• adults 18-65 years of age

• primary diagnosis of SAD, using Diagnostic Standard Manual(DSM-IV) criteria

• minimum Clinical Global Impression of Severity (CGI-S) score of 4 at baseline

• minimum Brief Social Phobia Scale(BSPS) score of 20 at baseline

• written informed consent

• negative serum pregnancy test for women of childbearing potential

• normal EKG

Exclusion Criteria:

• current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition

• any current primary anxiety disorder other than SAD

• current primary depression

• history of substance abuse or dependence within the last 3 months

• suicide risk or serious suicide attempt within the last year

• clinically significant medical condition or laboratory or EKG abnormality

• women of childbearing potential who are unwilling to practice an acceptable method of contraception

• patients needing concurrent use of psychotropic medications

• history of hypersensitivity to sertraline or ziprasidone

• recent (less than 2 months) initiation of psychotherapy for SAD

• history of failure to respond to augmentation with an adequate trial of an atypical antipsychotic

• patients who are currently taking any of the following medications: Erythromycin, Biaxin, Avelox, Zithromax, Amantadine, Levaquin, Tamoxifen, Tegretol, Nizoral, and Levitra

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:
• Ziprasidone
Sertraline augmentation with ziprasidone
• Sertraline
Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (1)

Davidson JR, Potts NL, Richichi EA, Ford SM, Krishnan KR, Smith RD, Wilson W. The Brief Social Phobia Scale. J Clin Psychiatry. 1991 Nov;52 Suppl:48-51. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Social Phobia Scale(BSPS)	An observer measure of social phobic symptoms, referred to as the Brief Social Phobia Scale, consists of 11 items, 7 evaluating commonly feared or avoided situations and 4 additional items measuring autonomic distress. A total numerical range of 0-88 is scored on this measure, with higher scores representing greater severity of social anxiety disorder symptoms.The total score is computed as a simple sum of the 11 items.	Baseline, 8 and 16 weeks	No