Geodon in Social Anxiety Disorder - Full Text View

Sponsors and Collaborators:	Duke University Pfizer
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00215150

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 II Phase III

MedlinePlus related topics: Anxiety

Drug Information available for: Sertraline hydrochloride Sertraline Ziprasidone Ziprasidone hydrochloride Ziprasidone mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Ziprasidone for the Treatment of Refractory Social Anxiety Disorder

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

Study ID Numbers:	6479
Study First Received:	September 20, 2005
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00215150
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duke University:

anxiety disorder
SAD
ziprasidone

sertraline
antidepressant
antipsychotic

Study placed in the following topic categories:

Dopamine
Anxiety Disorders
Mental Disorders
Sertraline

Ziprasidone
Phobic Disorders
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents

Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Antagonists
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 14, 2009