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

Primary Purpose

Social Anxiety Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ziprasidone
Sertraline
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder focused on measuring anxiety disorder, SAD, ziprasidone, sertraline, antidepressant, antipsychotic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Medical Center
  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Open Label Treatment

Randomization Ziprasidone

Randomization Placebo

Arm Description

8 weeks of open label treatment with sertraline

8 weeks of treatment with sertraline augmented with ziprasidone

8 weeks of treatment with sertraline augmented by placebo

Outcomes

Primary Outcome Measures

Brief Social Phobia Scale(BSPS)
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.

Secondary Outcome Measures

Full Information

First Posted
September 20, 2005
Last Updated
October 23, 2014
Sponsor
Duke University
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00215150
Brief Title
Geodon for the Treatment of Refractory Social Anxiety Disorder
Acronym
SAD
Official Title
Ziprasidone for the Treatment of Refractory Social Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
Keywords
anxiety disorder, SAD, ziprasidone, sertraline, antidepressant, antipsychotic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Label Treatment
Arm Type
Other
Arm Description
8 weeks of open label treatment with sertraline
Arm Title
Randomization Ziprasidone
Arm Type
Other
Arm Description
8 weeks of treatment with sertraline augmented with ziprasidone
Arm Title
Randomization Placebo
Arm Type
Other
Arm Description
8 weeks of treatment with sertraline augmented by placebo
Intervention Type
Drug
Intervention Name(s)
Ziprasidone
Other Intervention Name(s)
Geodon
Intervention Description
Sertraline augmentation with ziprasidone
Intervention Type
Drug
Intervention Name(s)
Sertraline
Other Intervention Name(s)
Zoloft
Intervention Description
Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase
Primary Outcome Measure Information:
Title
Brief Social Phobia Scale(BSPS)
Description
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.
Time Frame
Baseline, 8 and 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Zhang, M.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1757457
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.
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Geodon for the Treatment of Refractory Social Anxiety Disorder

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