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

• ClinicalTrials.gov Identifier: NCT00215150
• Recruitment Status: Completed
• First Posted: September 22, 2005
• Results First Posted: May 24, 2013
• Last Update Posted: October 31, 2014
• Sponsor: Duke University
• Collaborator: Pfizer
• Information provided by (Responsible Party): Duke University

Study Description

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

Condition or disease	Intervention/treatment	Phase
Social Anxiety Disorder	Drug: Ziprasidone; Drug: Sertraline	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Ziprasidone for the Treatment of Refractory Social Anxiety Disorder
• Study Start Date: November 2004
• Actual Primary Completion Date: December 2008
• Actual Study Completion Date: July 2009

Arms and Interventions

Arm	Intervention/treatment
Open Label Treatment; 8 weeks of open label treatment with sertraline	Drug: Sertraline; Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase; Other Name: Zoloft
Randomization Ziprasidone; 8 weeks of treatment with sertraline augmented with ziprasidone	Drug: Ziprasidone; Sertraline augmentation with ziprasidone; Other Name: Geodon; Drug: Sertraline; Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase; Other Name: Zoloft
Randomization Placebo; 8 weeks of treatment with sertraline augmented by placebo	Drug: Sertraline; Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase; Other Name: Zoloft

Outcome Measures

Primary Outcome Measures :

1. Brief Social Phobia Scale(BSPS) [ Time Frame: Baseline, 8 and 16 weeks ]
   An observer measure of social phobic symptoms, referred to as the Brief Social Phobia Scale, consists of 11 items, 7 evaluating commonly feared or avoided situations and 4 additional items measuring autonomic distress. A total numerical range of 0-88 is scored on this measure, with higher scores representing greater severity of social anxiety disorder symptoms.The total score is computed as a simple sum of the 11 items.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27701

Duke University Medical Center

Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

Pfizer

Investigators

• Principal Investigator: Wei Zhang, M.D.; Duke University

More Information

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.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT00215150
• Other Study ID Numbers: Pro00012882; 6479 ( Other Identifier: Duke legacy protocol number )
• First Posted: September 22, 2005
• Results First Posted: May 24, 2013
• Last Update Posted: October 31, 2014
• Last Verified: April 2013

Keywords provided by Duke University:

anxiety disorder; SAD; ziprasidone; sertraline; antidepressant; antipsychotic

Additional relevant MeSH terms:

Disease; Anxiety Disorders; Phobia, Social; Pathologic Processes; Mental Disorders; Phobic Disorders; Ziprasidone; Sertraline; Antidepressive Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Serotonin Antagonists; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Dopamine Antagonists; Dopamine Agents