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

This study has been completed.
Janssen, LP
Information provided by (Responsible Party):
VA Office of Research and Development Identifier:
First received: December 21, 2004
Last updated: August 5, 2014
Last verified: August 2014
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.

Condition Intervention Phase
Stress Disorders
Drug: Risperidone
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CSP #504 - Risperidone Treatment for Military Service Related Chronic Post-Traumatic Stress Disorder

Resource links provided by NLM:

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Change in CAPS Score From Baseline to Week 24 [ Time Frame: 24 Weeks ]
    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.

Enrollment: 296
Study Start Date: October 2006
Study Completion Date: January 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
Drug: Placebo
Other Name: Suger Pill

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 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00099983

  Show 20 Study Locations
Sponsors and Collaborators
VA Office of Research and Development
Janssen, LP
Study Chair: John H. Krystal VA Connecticut Health Care System (West Haven)
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: VA Office of Research and Development Identifier: NCT00099983     History of Changes
Other Study ID Numbers: 504
Study First Received: December 21, 2004
Results First Received: August 6, 2013
Last Updated: August 5, 2014

Keywords provided by VA Office of Research and Development:

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents processed this record on May 25, 2017