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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00099983
First Posted: December 22, 2004
Last Update Posted: August 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: August 6, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Stress Disorders
Post-Traumatic
Interventions: Drug: Risperidone
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited initially from 20 VA Medical Centers over a 2-year period. To address low recruitment rates and other issues, 8 sites were discontinued and 6 sites were added during the course of the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Risperidone

an atypical antipsychotic indicated for the treatment of schizophrenia but not for Post Traumatic Stress Disorder (PTSD). Some of additional unlabeled uses of risperidone include behavioral symptoms associated with dementia in the elderly, bipolar disorder, Tourette’s disorder, pervasive developmental disorder and autism.

(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).

Sugar Pill Placebo Sugar Pill 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).

Participant Flow:   Overall Study
    Risperidone   Sugar Pill
STARTED   147   149 
COMPLETED   123   124 
NOT COMPLETED   24   25 
Lost to Follow-up                2                3 
Missing Source Documents                14                15 
Withdrawal by Subject                3                2 
Adverse Event                1                1 
Lack of Efficacy                0                1 
Unable to return for appointments                1                1 
Moved                1                0 
Other psychiatric problem                1                0 
Incarcerated                0                1 
Intolerant of burden of visits                0                1 
Other issue                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Valid diagnostic baseline data were collected on 267 patients randomized to receive risperidone (n=133) and placebo (n=134). The 29 patients with "missing source documents" as reported in Participant Flow were not included in any analyses.

Reporting Groups
  Description
Risperidone Risperidone : atypical antipsychotic
Sugar Pill

PTSD

Placebo : Placebo

Total Total of all reporting groups

Baseline Measures
   Risperidone   Sugar Pill   Total 
Overall Participants Analyzed 
[Units: Participants]
 133   134   267 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   133   134   267 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.3  (10.8)   54.5  (10.6)   54.4  (10.7) 
Gender 
[Units: Participants]
     
Female   5   4   9 
Male   128   130   258 
Region of Enrollment 
[Units: Participants]
     
United States   133   134   267 


  Outcome Measures

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: John Krystal, MD
Organization: VA Connecticut HCS
phone: 203-937-4790
e-mail: john.krystal@yale.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00099983     History of Changes
Other Study ID Numbers: 504
First Submitted: December 21, 2004
First Posted: December 22, 2004
Results First Submitted: August 6, 2013
Results First Posted: August 22, 2014
Last Update Posted: August 22, 2014



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