Geodon for the Treatment of Refractory Social Anxiety Disorder (SAD)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00215150
First received: September 20, 2005
Last updated: July 14, 2014
Last verified: April 2013

September 20, 2005
July 14, 2014
November 2004
December 2008   (final data collection date for primary outcome measure)
Brief Social Phobia Scale(BSPS) [ Time Frame: Baseline, 8 and 16 weeks ] [ Designated as safety issue: No ]
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.
Brief Social Phobia Scale (BSPS)
Complete list of historical versions of study NCT00215150 on ClinicalTrials.gov Archive Site
Not Provided
Clinical Global Impression of Severity (CGI-S)
Not Provided
Not Provided
 
Geodon for the Treatment of Refractory Social Anxiety Disorder
Ziprasidone for the Treatment of Refractory Social Anxiety Disorder

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Social Anxiety Disorder
  • Drug: Ziprasidone
    Sertraline augmentation with ziprasidone
    Other Name: Geodon
  • Drug: Sertraline
    Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase
    Other Name: Zoloft
  • Open Label Treatment
    8 weeks of open label treatment with sertraline
    Intervention: Drug: Sertraline
  • Randomization Ziprasidone
    8 weeks of treatment with sertraline augmented with ziprasidone
    Interventions:
    • Drug: Ziprasidone
    • Drug: Sertraline
  • Randomization Placebo
    8 weeks of treatment with sertraline augmented by placebo
    Intervention: Drug: Sertraline
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
July 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00215150
Pro00012882 (6479), 6479
No
Duke University
Duke University
Pfizer
Principal Investigator: Wei Zhang, M.D. Duke University
Duke University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP