ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00099983
Recruitment Status : Completed
First Posted : December 22, 2004
Results First Posted : August 22, 2014
Last Update Posted : August 22, 2014
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

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
Enrollment 296

Recruitment Details 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  
Arm/Group Title Risperidone Sugar Pill
Hide Arm/Group Description

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).

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).
Period Title: Overall Study
Started 147 149
Completed 123 124
Not Completed 24 25
Reason Not Completed
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
Arm/Group Title Risperidone Sugar Pill Total
Hide Arm/Group Description Risperidone : atypical antipsychotic

PTSD

Placebo : Placebo

Total of all reporting groups
Overall Number of Baseline Participants 133 134 267
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 134 participants 267 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
133
 100.0%
134
 100.0%
267
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 133 participants 134 participants 267 participants
54.3  (10.8) 54.5  (10.6) 54.4  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 134 participants 267 participants
Female
5
   3.8%
4
   3.0%
9
   3.4%
Male
128
  96.2%
130
  97.0%
258
  96.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 133 participants 134 participants 267 participants
133 134 267
1.Primary Outcome
Title Change in CAPS Score From Baseline to Week 24
Hide Description 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.
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Risperidone Sugar Pill
Hide Arm/Group Description:

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

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.

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

Placebo: Placebo

Overall Number of Participants Analyzed 123 124
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-16.3
(-19.7 to -12.9)
-12.5
(-15.7 to -9.4)
Time Frame Within 72 hours of site being made aware of event.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Risperidone Sugar Pill
Hide Arm/Group Description Risperidone : atypical antipsychotic

PTSD

Placebo : Placebo

All-Cause Mortality
Risperidone Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Risperidone Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/133 (12.03%)      10/134 (7.46%)    
Gastrointestinal disorders     
Gastrooesphageal reflus Disease  1  0/133 (0.00%)  0 1/134 (0.75%)  1
Intestinal Obstruction  1  0/133 (0.00%)  0 1/134 (0.75%)  1
General disorders     
Non-cardiac  1  0/133 (0.00%)  0 1/134 (0.75%)  1
Oedema Peripheral  1  1/133 (0.75%)  1 0/134 (0.00%)  0
Infections and infestations     
Appendicitis  1  3/133 (2.26%)  3 0/134 (0.00%)  0
Infections  1  3/133 (2.26%)  3 0/134 (0.00%)  0
Injury, poisoning and procedural complications     
Injury  1  0/133 (0.00%)  0 2/134 (1.49%)  2
Psychiatric disorders     
Suicidal ideation  1  8/133 (6.02%)  8 2/134 (1.49%)  2
Aggression  1  0/133 (0.00%)  0 1/134 (0.75%)  1
Respiratory, thoracic and mediastinal disorders     
Pulmonary  1  1/133 (0.75%)  1 2/134 (1.49%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Risperidone Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/133 (0.00%)      0/134 (0.00%)    
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
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
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