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Geodon in Social Anxiety Disorder (SAD)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00215150
First received: September 20, 2005
Last updated: June 9, 2010
Last verified: June 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Social Anxiety Disorder
 Drug: sertraline and ziprasidone
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Ziprasidone for the Treatment of Refractory Social Anxiety Disorder

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Brief Social Phobia Scale (BSPS)

Secondary Outcome Measures:
  • Clinical Global Impression of Severity (CGI-S)

Estimated Enrollment: 40
Study Start Date: November 2004
Study Completion Date: January 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults 18-65 years of age
  • primary diagnosis of SAD, using DSM-IV criteria
  • minimum CGI-S score of 4 at baseline
  • minimum 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00215150

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27701
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Pfizer
Investigators
Principal Investigator: Wei Zhang, M.D. Duke University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00215150     History of Changes
Other Study ID Numbers: 6479
Study First Received: September 20, 2005
Last Updated: June 9, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
anxiety disorder
SAD
ziprasidone
 sertraline
antidepressant
antipsychotic

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Mental Disorders
Sertraline
Ziprasidone
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
 Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Serotonin Antagonists
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 19, 2013