Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder (CSP #504)

This study has been completed.
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00099983
First received: December 21, 2004
Last updated: August 5, 2014
Last verified: August 2014

December 21, 2004
August 5, 2014
October 2006
February 2010   (final data collection date for primary outcome measure)
Change in CAPS Score From Baseline to Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
The primary outcome measure for this study was the total score on the 34-item Clinician-Administered PTSD Scale (CAPS). This study was the intent-to-treat analysis of the improvement in PTSD symptoms from baseline to week-24 follow-up as measured by the CAPS. Total score range for the CAPS is 0-136 with higher values representing a worse outcome. This study was powered initially to detect a 9-point difference between the treatment groups in the CAPS change score.
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Complete list of historical versions of study NCT00099983 on ClinicalTrials.gov Archive Site
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Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder
CSP #504 - Risperidone Treatment for Military Service Related Chronic Post-Traumatic Stress Disorder

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.

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 0.05 for the overall test for the CAPS score change.

STUDY UPDATE/NOTES: 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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Stress Disorders
  • Post-Traumatic
  • Drug: Risperidone
    Initiate treatment with a low dose (1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day). Reduction to a lower dose will be allowed at any time, based on adverse effects. Treatment will continue for 6 months. Patients who discontinue treatment will be allowed to resume treatment at any time.
    Other Name: Risperdal
  • Drug: Placebo
    Placebo
    Other Name: Suger Pill
  • Active Comparator: Risperidone
    1 mg/day tablet for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day to a maximum of 4 mg/day allowed after a minimum of 4 weeks at the target dose 3 mg/day
    Intervention: Drug: Risperidone
  • Placebo Comparator: Sugar Pill
    Placebo 1 mg/day tablet for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day to a maximum of 4 mg/day allowed after a minimum of 4 weeks at the target dose 3 mg/day
    Intervention: Drug: Placebo
Krystal JH, Rosenheck RA, Cramer JA, Vessicchio JC, Jones KM, Vertrees JE, Horney RA, Huang GD, Stock C; Veterans Affairs Cooperative Study No. 504 Group. Adjunctive risperidone treatment for antidepressant-resistant symptoms of chronic military service-related PTSD: a randomized trial. JAMA. 2011 Aug 3;306(5):493-502. doi: 10.1001/jama.2011.1080.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
296
January 2011
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years or older
  • Military service related chronic PTSD
  • CAPS score >50
  • Participant in VA outpatient PTSD clinic
  • History of non-response to two or more antidepressants

Exclusion Criteria:

  • Comorbid Axis I diagnosis requiring antipsychotic medication
  • Substance dependence diagnosis (excluding nicotine)
  • Hepatic or renal problems
  • Incompatible medical diagnosis or medication (i.e., coumadin, insulin)
  • Unstable living arrangements
  • Assault or suicide gesture within 1 year
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00099983
504
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Janssen, LP
Study Chair: John H. Krystal VA Connecticut Health Care System (West Haven)
Department of Veterans Affairs
August 2014

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