CSP #504 - Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder - Full Text View

Sponsors and Collaborators:	Department of Veterans Affairs Janssen, LP
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00099983

Purpose

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, Post-Traumatic	Drug: Risperidone	Phase II

MedlinePlus related topics: Post-Traumatic Stress Disorder Stress

Drug Information available for: Risperidone

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study

Official Title:

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

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Change in CAPS Score from Baseline to Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:

400

Study Start Date:

October 2006

Estimated Study Completion Date:

January 2011

Estimated Primary Completion Date:

July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Drug: Risperidone

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.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099983

Contacts

Contact: Karen M Jones, MS	(410) 642-2411 ext 5297	karen.jones2@va.gov
Contact: Shannon Affleck	(410) 642-2411 ext 5432	Shannon.Affleck@va.gov

Show 20 Study Locations

Sponsors and Collaborators

Department of Veterans Affairs

Janssen, LP

Investigators

Study Chair:

John H. Krystal

VA Connecticut Health Care System (West Haven)

More Information

Responsible Party:

Department of Veterans Affairs ( Krystal, John - Study Chair )

Study ID Numbers:

504

First Received:

December 21, 2004

Last Updated:

October 9, 2008

ClinicalTrials.gov Identifier:

NCT00099983

Health Authority:

United States: Federal Government

Keywords provided by Department of Veterans Affairs:

PTSD

Study placed in the following topic categories:

Dopamine
Anxiety Disorders
Mental Disorders
Risperidone

Stress Disorders, Post-Traumatic
Stress
Serotonin
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 07, 2009