Overview
Geodon for the Treatment of Refractory Social Anxiety Disorder
Status:
Completed
Completed
Trial end date:
2009-07-01
2009-07-01
Target enrollment:
0
0
Participant gender:
All
All
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 alonePhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Duke UniversityCollaborator:
PfizerTreatments:
Sertraline
Ziprasidone
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