DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Geodon for the Treatment of Refractory Social Anxiety Disorder

Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Social Anxiety Disorder

Intervention: Ziprasidone (Drug); Sertraline (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Duke University

Official(s) and/or principal investigator(s):
Wei Zhang, M.D., Principal Investigator, Affiliation: Duke University

Summary

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

Clinical Details

Official title: Ziprasidone for the Treatment of Refractory Social Anxiety Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Brief Social Phobia Scale(BSPS)

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Duke University Medical Center, Durham, North Carolina 27701, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Additional Information

Related publications:

Davidson JR, Potts NL, Richichi EA, Ford SM, Krishnan KR, Smith RD, Wilson W. The Brief Social Phobia Scale. J Clin Psychiatry. 1991 Nov;52 Suppl:48-51.

Starting date: November 2004
Last updated: October 23, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017