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

October 23, 2014 updated by: Duke University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

51

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Durham, North Carolina, United States, 27701
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Open Label Treatment
8 weeks of open label treatment with sertraline
Drug: Sertraline
Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase
Other Names:
  • Zoloft
Other: Randomization Ziprasidone
8 weeks of treatment with sertraline augmented with ziprasidone
Drug: Sertraline
Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase
Other Names:
  • Zoloft
Drug: Ziprasidone
Sertraline augmentation with ziprasidone
Other Names:
  • Geodon
Other: Randomization Placebo
8 weeks of treatment with sertraline augmented by placebo
Drug: Sertraline
Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase
Other Names:
  • Zoloft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 8 and 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Pfizer

Investigators

  • Principal Investigator: Wei Zhang, M.D., Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

September 20, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

October 31, 2014

Last Update Submitted That Met QC Criteria

October 23, 2014

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00012882
  • 6479 (Other Identifier: Duke legacy protocol number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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