PTSD Clinical Trial
Official title:
Geodon (Ziprasidone) for Posttraumatic Stress Disorder
Verified date | April 2005 |
Source | Creighton University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 80 |
Est. completion date | April 2005 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 19 Years to 64 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Creighton University Psychiatry and Research Center | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
Creighton University | Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response to ziprasidone or placebo (inactive drug) will be measured by Clinician Administered PTSD Scale (CAPS) and Treatment Outcomes PTSD Scale (TOP-8). | |||
Secondary | 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. |
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