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Trial record 1 of 1 for:    NCT00215150
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Geodon for the Treatment of Refractory Social Anxiety Disorder (SAD)

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ClinicalTrials.gov Identifier: NCT00215150
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : May 24, 2013
Last Update Posted : October 31, 2014
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE September 20, 2005
First Posted Date  ICMJE September 22, 2005
Results First Submitted Date  ICMJE December 13, 2012
Results First Posted Date  ICMJE May 24, 2013
Last Update Posted Date October 31, 2014
Study Start Date  ICMJE November 2004
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2013)
Brief Social Phobia Scale(BSPS) [ Time Frame: Baseline, 8 and 16 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 20, 2005)
Brief Social Phobia Scale(BSPS)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2005)
Clinical Global Impression of Severity (CGI-S)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Geodon for the Treatment of Refractory Social Anxiety Disorder
Official Title  ICMJE Ziprasidone for the Treatment of Refractory Social Anxiety Disorder
Brief 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
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Social Anxiety Disorder
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2013)
51
Original Enrollment  ICMJE
 (submitted: September 20, 2005)
40
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00215150
Other Study ID Numbers  ICMJE Pro00012882
6479 ( Other Identifier: Duke legacy protocol number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Wei Zhang, M.D. Duke University
PRS Account Duke University
Verification Date April 2013

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