Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208208
Status:
COMPLETED
Last Update Posted:
2006-09-15
First Post:
2005-09-14
Brief Title:
Geodon Ziprasidone for Posttraumatic Stress Disorder
Sponsor:
Creighton University
Organization:
Creighton University
Study Overview
Official Title:
Geodon Ziprasidone for Posttraumatic Stress Disorder
Status:
COMPLETED
Status Verified Date:
2005-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Grant 2001-0261 | None | None | None |