Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208182
Status:
COMPLETED
Last Update Posted:
2006-03-10
First Post:
2005-09-13
Brief Title:
Risperidone in the Treatment of PTSD in Women Survivors of Domestic Abuse and Rape Trauma
Sponsor:
Creighton University
Organization:
Creighton University
Study Overview
Official Title:
Risperidone Monotherapy in the Treatment of PTSD in Women Survivors of Domestic Abuse and Rape Trauma a Double-Blind Placebo Controlled Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2006-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This medical study is an assessment of clinical response in women with Posttraumatic Stress Disorder PTSD due to domestic violence or rape trauma when treated with risperidone Response to risperidone or placebo inactive drug is measured by Clinician Administered PTSD Scale CAPS and Treatment Outcomes PTSD Scale TOP-8 Second the effect of risperidone on depressive and anxiety symptoms will be assessed using the Hamilton Rating Scale for Anxiety Hamilton Rating Scale for Depression and the Clinical Global Impression
Detailed Description:
Risperidone is an atypical antipsychotic that has been shown to be effective in both the core PTSD symptoms and psychotic symptoms associated with combat-induced PTSD in males Case series have shown that risperidone is possibly effective in monotherapy or adjunctively in treating PTSD patients However risperidone has never been tested in women with severe PTSD Thus we propose extending and expanding this research to another antipsychotic risperidone in a cohort of women who suffer PTSD as a consequence of domestic violence andor rape trauma
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