Status:
COMPLETED
Geodon (Ziprasidone) for Posttraumatic Stress Disorder
Lead Sponsor:
Creighton University
Collaborating Sponsors:
Pfizer
Conditions:
Posttraumatic Stress Disorder
Post-Traumatic Stress Disorder
Eligibility:
All Genders
19-64 years
Phase:
PHASE4
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 p...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00208208
Start Date
December 1 2002
End Date
April 1 2005
Last Update
September 15 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Creighton University Psychiatry and Research Center
Omaha, Nebraska, United States, 68131