Trial Outcomes & Findings for Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder (NCT NCT00099983)
NCT ID: NCT00099983
Last Updated: 2014-08-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
296 participants
Primary outcome timeframe
24 Weeks
Results posted on
2014-08-22
Participant Flow
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.
Participant milestones
| Measure |
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).
|
|---|---|---|
|
Overall Study
STARTED
|
147
|
149
|
|
Overall Study
COMPLETED
|
123
|
124
|
|
Overall Study
NOT COMPLETED
|
24
|
25
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Missing Source Documents
|
14
|
15
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Unable to return for appointments
|
1
|
1
|
|
Overall Study
Moved
|
1
|
0
|
|
Overall Study
Other psychiatric problem
|
1
|
0
|
|
Overall Study
Incarcerated
|
0
|
1
|
|
Overall Study
Intolerant of burden of visits
|
0
|
1
|
|
Overall Study
Other issue
|
1
|
0
|
Baseline Characteristics
Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
Risperidone
n=133 Participants
Risperidone : atypical antipsychotic
|
Sugar Pill
n=134 Participants
PTSD
Placebo : Placebo
|
Total
n=267 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
133 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
267 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
54.3 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
54.5 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
54.4 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
128 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
258 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
133 participants
n=5 Participants
|
134 participants
n=7 Participants
|
267 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 WeeksThe 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.
Outcome measures
| Measure |
Risperidone
n=123 Participants
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.
|
Sugar Pill
n=124 Participants
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
|
|---|---|---|
|
Change in CAPS Score From Baseline to Week 24
|
-16.3 units on a scale
Interval -19.7 to -12.9
|
-12.5 units on a scale
Interval -15.7 to -9.4
|
Adverse Events
Risperidone
Serious events: 16 serious events
Other events: 0 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Risperidone
n=133 participants at risk
Risperidone : atypical antipsychotic
|
Sugar Pill
n=134 participants at risk
PTSD
Placebo : Placebo
|
|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
6.0%
8/133 • Number of events 8 • Within 72 hours of site being made aware of event.
|
1.5%
2/134 • Number of events 2 • Within 72 hours of site being made aware of event.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/133 • Within 72 hours of site being made aware of event.
|
0.75%
1/134 • Number of events 1 • Within 72 hours of site being made aware of event.
|
|
Gastrointestinal disorders
Gastrooesphageal reflus Disease
|
0.00%
0/133 • Within 72 hours of site being made aware of event.
|
0.75%
1/134 • Number of events 1 • Within 72 hours of site being made aware of event.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/133 • Within 72 hours of site being made aware of event.
|
0.75%
1/134 • Number of events 1 • Within 72 hours of site being made aware of event.
|
|
General disorders
Non-cardiac
|
0.00%
0/133 • Within 72 hours of site being made aware of event.
|
0.75%
1/134 • Number of events 1 • Within 72 hours of site being made aware of event.
|
|
General disorders
Oedema Peripheral
|
0.75%
1/133 • Number of events 1 • Within 72 hours of site being made aware of event.
|
0.00%
0/134 • Within 72 hours of site being made aware of event.
|
|
Infections and infestations
Appendicitis
|
2.3%
3/133 • Number of events 3 • Within 72 hours of site being made aware of event.
|
0.00%
0/134 • Within 72 hours of site being made aware of event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
0.75%
1/133 • Number of events 1 • Within 72 hours of site being made aware of event.
|
1.5%
2/134 • Number of events 2 • Within 72 hours of site being made aware of event.
|
|
Infections and infestations
Infections
|
2.3%
3/133 • Number of events 3 • Within 72 hours of site being made aware of event.
|
0.00%
0/134 • Within 72 hours of site being made aware of event.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/133 • Within 72 hours of site being made aware of event.
|
1.5%
2/134 • Number of events 2 • Within 72 hours of site being made aware of event.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place