Geodon for the Treatment of Refractory Social Anxiety Disorder

Completed · Phase 2 · Has a placebo group

Conditions studied: Social Anxiety Disorder

In brief

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

Key facts

Study ID

NCT00215150

Run by

Duke University

People needed

51

Starts

2004-11-01

Expected to finish

2009-07-01

Last updated by the study team

2014-10-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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