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Geodon (Ziprasidone) for Posttraumatic Stress Disorder

Primary Purpose

Posttraumatic Stress Disorder, Post-Traumatic Stress Disorder, PTSD

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ziprasidone
Sponsored by
Creighton University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic Stress Disorder, Post-traumatic Stress Disorder, PTSD, Geodon, Ziprasidone

Eligibility Criteria

19 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Men & women with DSM-IV clinical diagnosis of PTSD who are able to attend weekly clinic appointments Age 19-64, not pregnant and either sterile or using a medically acceptable method of birth control A willingness and ability to provide competent signed informed consent A level of understanding sufficient to perform all tests and examinations required by the protocol (including fluency of spoken English) Exclusion Criteria: Any diagnosis of schizophrenia or bipolar I disorder, or active substance dependence Unstable general medical condition or serious illness (e.g.. death or hospitalization is anticipated within one year), poor kidney function, liver function (defined as lab values ≥ three times the upper limit of the laboratory normal) and seizure disorders with the exception of childhood seizure disorders. Subjects with prior non-response to Geodon for the treatment of PTSD with an adequate trial Enrollment in any study drug within the last 30 days. Current pharmacotherapy is permitted, provided that the medication and dose have been stable for the past 90 days. Pregnancy or nursing Any subject judged clinically to be at serious suicidal risk in the opinion of the investigator

Sites / Locations

  • Creighton University Psychiatry and Research Center

Outcomes

Primary Outcome Measures

Response to ziprasidone or placebo (inactive drug) will be measured by Clinician Administered PTSD Scale (CAPS) and Treatment Outcomes PTSD Scale (TOP-8).

Secondary Outcome Measures

A secondary aim of the study is to measure effects on depression and anxiety symptoms in the same persons, using the HAM-A, HAM-D and the CGI. Quality of life will also be assessed using the QOLI.

Full Information

First Posted
September 14, 2005
Last Updated
September 14, 2006
Sponsor
Creighton University
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00208208
Brief Title
Geodon (Ziprasidone) for Posttraumatic Stress Disorder
Official Title
Geodon (Ziprasidone) for Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2005
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Creighton University
Collaborators
Pfizer

4. Oversight

5. Study Description

Brief Summary
Atypical antipsychotics have shown promise in the treatment of depression and anxiety, which are prominent symptoms of PTSD. The profile of the atypical antipsychotic, ziprasidone (Geodon), suggests possible anxiolytic and antidepressant properties. This research will assess the potential effectiveness of Geodon in civilian men and women who suffer from severe PTSD. Response to ziprasidone or placebo will be measured by Clinician Administered PTSD Scale (CAPS) and Treatment Outcomes PTSD Scale (TOP-8).
Detailed Description
PTSD is a common disorder with 10% lifetime prevalence among Americans. The major causes of PTSD are sexual assault, accidents, disasters Despite this public health burden, only two drugs, sertraline (Zoloft) and paroxetine (Paxil), are approved by the FDA for the treatment of PTSD. New options for the treatment of PTSD are much needed. Approximately half of patients with PTSD respond to Zoloft and Paxil. Many patients experience psychotic symptoms with PTSD, which may not respond to treatment to Zoloft and Paxil. Though classified as an anxiety disorder in the DSM-IV, PTSD is accompanied by psychotic symptoms in almost half of patients (Butler et al 1996; Hamner et al 1999, Lindley et al 2000). Also, PTSD has an extensive comorbidity with major depressive disorder (Davis et al 2000). While Geodon is approved by the FDA in the United States for the treatment of psychosis, it has not been evaluated for the treatment of PTSD . A clinical trial of Geodon in PTSD will help delineate the potential antidepressant spectrum of efficacy of Geodon as well as its anxiolytic profile.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Post-Traumatic Stress Disorder, PTSD
Keywords
Posttraumatic Stress Disorder, Post-traumatic Stress Disorder, PTSD, Geodon, Ziprasidone

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ziprasidone
Primary Outcome Measure Information:
Title
Response to ziprasidone or placebo (inactive drug) will be measured by Clinician Administered PTSD Scale (CAPS) and Treatment Outcomes PTSD Scale (TOP-8).
Secondary Outcome Measure Information:
Title
A secondary aim of the study is to measure effects on depression and anxiety symptoms in the same persons, using the HAM-A, HAM-D and the CGI. Quality of life will also be assessed using the QOLI.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men & women with DSM-IV clinical diagnosis of PTSD who are able to attend weekly clinic appointments Age 19-64, not pregnant and either sterile or using a medically acceptable method of birth control A willingness and ability to provide competent signed informed consent A level of understanding sufficient to perform all tests and examinations required by the protocol (including fluency of spoken English) Exclusion Criteria: Any diagnosis of schizophrenia or bipolar I disorder, or active substance dependence Unstable general medical condition or serious illness (e.g.. death or hospitalization is anticipated within one year), poor kidney function, liver function (defined as lab values ≥ three times the upper limit of the laboratory normal) and seizure disorders with the exception of childhood seizure disorders. Subjects with prior non-response to Geodon for the treatment of PTSD with an adequate trial Enrollment in any study drug within the last 30 days. Current pharmacotherapy is permitted, provided that the medication and dose have been stable for the past 90 days. Pregnancy or nursing Any subject judged clinically to be at serious suicidal risk in the opinion of the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick Petty, MD, PhD
Organizational Affiliation
Creighton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Creighton University Psychiatry and Research Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States

12. IPD Sharing Statement

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Geodon (Ziprasidone) for Posttraumatic Stress Disorder

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