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
  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: Ziprasidone
Drug: Sertraline
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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.


Enrollment: 51
Study Start Date: November 2004
Study Completion Date: July 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Zoloft
Randomization Ziprasidone
8 weeks of treatment with sertraline augmented with ziprasidone
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
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 Name: Zoloft

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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00215150     History of Changes
Other Study ID Numbers: Pro00012882 (6479), 6479
Study First Received: September 20, 2005
Results First Received: December 13, 2012
Last Updated: July 14, 2014
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
Disease
Mental Disorders
Pathologic Processes
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 September 16, 2014