Phase 2 N=51 Randomized Triple-blind Treatment

Geodon for the Treatment of Refractory Social Anxiety Disorder

Social Anxiety Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00215150 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2013

Primary outcome: Primary: Brief Social Phobia Scale(BSPS) — 44.0; 31.8; 31.8; 31.2 units on a scale — p=< 0.001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ziprasidone (Drug); Sertraline (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Dec 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Brief Social Phobia Scale(BSPS)	44.0; 31.8; 31.8; 31.2; 21.0; 24.6	< 0.001 sig

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00215150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.