Geodon (Ziprasidone) for Posttraumatic Stress Disorder

NCT00208208

Last updated date
Study Location
Creighton University Psychiatry and Research Center
Omaha, Nebraska, 68131, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Posttraumatic Stress Disorder, Post-Traumatic Stress Disorder, PTSD
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
19-64 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Posttraumatic Stress Disorder, Post-Traumatic Stress Disorder, PTSDGeodon (Ziprasidone) for Posttraumatic Stress Disorder
NCT00208208
  1. Omaha, Nebraska
ALL GENDERS
19 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Geodon (Ziprasidone) for Posttraumatic Stress Disorder
Official Title  ICMJE Geodon (Ziprasidone) for Posttraumatic Stress Disorder
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
Condition  ICMJE
  • Posttraumatic Stress Disorder
  • Post-Traumatic Stress Disorder
  • PTSD
Intervention  ICMJE Drug: Ziprasidone
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 14, 2005)
80
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE April 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 19 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00208208
Other Study ID Numbers  ICMJE 2001-0261
Grant 2001-0261
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Creighton University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Frederick Petty, MD, PhDCreighton University
PRS Account Creighton University
Verification Date April 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP