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

Duke University

Status and phase: Completed; Phase 2

Conditions: Social Anxiety Disorder

Treatments: Drug: Sertraline; Drug: Ziprasidone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00215150

6479 (Other Identifier)

Pro00012882

Details and patient eligibility

About

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

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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51 participants in 3 patient groups

Open Label Treatment

Other group

Description:

8 weeks of open label treatment with sertraline

Treatment:

Drug: Sertraline

Randomization Ziprasidone

Other group

Description:

8 weeks of treatment with sertraline augmented with ziprasidone

Treatment:

Drug: Ziprasidone

Drug: Sertraline

Randomization Placebo

Other group

Description:

8 weeks of treatment with sertraline augmented by placebo

Treatment:

Drug: Sertraline