Geodon (Ziprasidone) for Posttraumatic Stress Disorder

NCT00208208 | Completed Phase 4

• 2 other identifiers: 2001-0261Grant 2001-0261
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Post-Traumatic Stress Disorder; PTSD

Keywords

Posttraumatic Stress Disorder; Post-traumatic Stress Disorder; PTSD; Geodon; Ziprasidone

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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.

Interventions

Ziprasidone DRUG

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Creighton University: lead
• Pfizer: collaborator

Study Sites (1)

Creighton University Psychiatry and Research Center

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Frederick Petty, MD, PhD

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 21, 2005
• Study Start: December 1, 2002
• Study Completion: April 1, 2005
• Last Updated: September 15, 2006

Record last verified: 2005-04

Locations

US (1)