Clinical trial NCT00215150: Geodon for the Treatment of Refractory Social Anxiety Disorder
Official title: Ziprasidone for the Treatment of Refractory Social Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Social Anxiety Disorder
Keywords: anxiety disorder
SAD
ziprasidone
sertraline
antidepressant
antipsychotic
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2005-09-22
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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 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

Primary outcomes:
measure: Brief Social Phobia Scale(BSPS)
timeFrame: Baseline, 8 and 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Wei Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1037/t07672-000.