Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099983
Status:
COMPLETED
Last Update Posted:
2014-08-22
First Post:
2004-12-21
Brief Title:
Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 504 - Risperidone Treatment for Military Service Related Chronic Post-Traumatic Stress Disorder
Status:
COMPLETED
Status Verified Date:
2014-08
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:
CSP 504
Brief Summary:
The purpose of this research of 400 participants is to determine whether a drug called risperidone can decrease symptoms of Post-Traumatic Stress Disorder PTSD It is a placebo-controlled study meaning that half of the participants will be assigned to receive a pill that contains no drug The treatment phase of the study will last for 6 months during which time participants will continue to receive all their usual treatments in addition to the study treatment and will be asked to complete procedures and assessments questionnaires interviews laboratory tests physical exams etc related to their PTSD symptoms at various points within the 6-month treatment phase At the end of the 6-month study participants will discontinue the study treatment
Detailed Description:
Primary Hypothesis Risperidone will reduce symptoms of PTSD relative to placebo in veterans with military service related chronic PTSD who have been partial or non-responders to antidepressant medications
Secondary Hypothesis Risperidone is safe and well-tolerated in veterans with military service related chronic PTSD and patients will comply with its prescription As a result patients will show improvement in the secondary consequences of PTSD for the veteran and for the VA
Intervention Usual PTSD care plus Risperidone vs usual PTSD care plus placebo Study Abstract Four hundred veterans with the diagnosis of military-related PTSD will be enrolled at 20 VAMC hospitals over a two-year period An equipoise stratification design will be used to randomize patients in a double-blind manner to risperidone or placebo 200 patients in each group for six months of treatment Usual care will be provided for all patients for treatment of PTSD and other psychiatric and medical disorders Comparisons between the risperidone and placebo groups will be made at the end of six months to answer the primary question The sample size is calculated to give 90 power at the two-sided alpha level of 005 for the overall test for the CAPS score change
STUDY UPDATENOTES The study kicked-off in late July 2006 with recruitment expected to begin October 1 2006
Oct2006 - Participating sites are seeking approval for the protocol amendment which resulted from the Kick-Off meeting Patient recruitment at each site will begin as soon as they receive approval of the amendment
Secondary Hypothesis Risperidone is safe and well-tolerated in veterans with military service related chronic PTSD and patients will comply with its prescription As a result patients will show improvement in the secondary consequences of PTSD for the veteran and for the VA
Intervention Usual PTSD care plus Risperidone vs usual PTSD care plus placebo Study Abstract Four hundred veterans with the diagnosis of military-related PTSD will be enrolled at 20 VAMC hospitals over a two-year period An equipoise stratification design will be used to randomize patients in a double-blind manner to risperidone or placebo 200 patients in each group for six months of treatment Usual care will be provided for all patients for treatment of PTSD and other psychiatric and medical disorders Comparisons between the risperidone and placebo groups will be made at the end of six months to answer the primary question The sample size is calculated to give 90 power at the two-sided alpha level of 005 for the overall test for the CAPS score change
STUDY UPDATENOTES The study kicked-off in late July 2006 with recruitment expected to begin October 1 2006
Oct2006 - Participating sites are seeking approval for the protocol amendment which resulted from the Kick-Off meeting Patient recruitment at each site will begin as soon as they receive approval of the amendment
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