Geodon (Ziprasidone) for Posttraumatic Stress Disorder

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Creighton University
• Collaborator: Pfizer
• Treatments: Ziprasidone

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