Trial Outcomes & Findings for Risperidone or Cognitive-Behavioral Therapy for Improving Medication Treatment for Obsessive-compulsive Disorder (NCT NCT00389493)
NCT ID: NCT00389493
Last Updated: 2014-04-25
Results Overview
Y-BOCS ranges from 0-40, with 0 meaning no symptoms and higher numbers meaning greater symptom severity
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
Week 0 and Week 8
Results posted on
2014-04-25
Participant Flow
A randomized clinical trial (conducted January 2007-August 2012) at 2 academic outpatient research clinics that specialize in OCD and anxiety disorders. Patients (aged 18-70 years) were eligible if they had OCD of at least moderate severity despite a therapeutic SRI dose for at least 12 weeks prior to entry.
Participant milestones
| Measure |
Treatment With Risperidone
Participants will receive treatment with risperidone
Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated
|
Treatment With Exposure/Response Prevention
Participants will receive exposure and response prevention therapy
Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.
|
Treatment With Pill Placebo
Participants will receive treatment with the placebo
Placebo : Placebo capsules will be identical in appearance to those of risperidone.
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
20
|
|
Overall Study
COMPLETED
|
37
|
32
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
8
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Risperidone or Cognitive-Behavioral Therapy for Improving Medication Treatment for Obsessive-compulsive Disorder
Baseline characteristics by cohort
| Measure |
Treatment With Risperidone
n=40 Participants
Participants will receive treatment with risperidone
Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated
|
Treatment With Exposure/Response Prevention
n=40 Participants
Participants will receive exposure and response prevention therapy
Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.
|
Treatment With Pill Placebo
n=20 Participants
Participants will receive treatment with the placebo
Placebo : Placebo capsules will be identical in appearance to those of risperidone.
|
Total
n=100 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
33.8 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
34.3 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
33.4 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
33.9 years
STANDARD_DEVIATION 11.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
20 participants
n=5 Participants
|
100 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 0 and Week 8Y-BOCS ranges from 0-40, with 0 meaning no symptoms and higher numbers meaning greater symptom severity
Outcome measures
| Measure |
Treatment With Risperidone
n=40 Participants
Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8
|
Treatment With Exposure/Response Prevention
n=40 Participants
Participants received exposure and response prevention therapy
Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.
Mean Y-BOCS score measured at week 8
|
Treatment With Pill Placebo
n=20 Participants
Participants received treatment with the placebo
Placebo : Placebo capsules will be identical in appearance to those of risperidone.
Mean Y-BOCS score measured at week 8
|
|---|---|---|---|
|
Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Y-BOCS score at Week 0
|
26.1 units on a scale
Standard Deviation 4.3
|
27.2 units on a scale
Standard Deviation 3.9
|
25.9 units on a scale
Standard Deviation 4.6
|
|
Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Y-BOCS score at Week 8
|
22.6 units on a scale
Standard Deviation 8.8
|
13.0 units on a scale
Standard Deviation 6.1
|
23.1 units on a scale
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: Week 0 and Week 8SAS-SR yields a mean score between 1 and 5; the higher the score, the more severe the social adjustment problems
Outcome measures
| Measure |
Treatment With Risperidone
n=40 Participants
Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8
|
Treatment With Exposure/Response Prevention
n=40 Participants
Participants received exposure and response prevention therapy
Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.
Mean Y-BOCS score measured at week 8
|
Treatment With Pill Placebo
n=20 Participants
Participants received treatment with the placebo
Placebo : Placebo capsules will be identical in appearance to those of risperidone.
Mean Y-BOCS score measured at week 8
|
|---|---|---|---|
|
Social Adjustment Scale-SR
SAS-SR at Week 0
|
2.3 units on a scale
Standard Deviation 0.4
|
2.3 units on a scale
Standard Deviation 0.5
|
2.2 units on a scale
Standard Deviation 0.7
|
|
Social Adjustment Scale-SR
SAS-SR at Week 8
|
2.2 units on a scale
Standard Deviation 0.4
|
1.9 units on a scale
Standard Deviation 0.4
|
2.1 units on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Week 0 and Week 8QLESQ ranges from 14-70, with higher scores meaning more enjoyment and satisfaction with quality of life
Outcome measures
| Measure |
Treatment With Risperidone
n=40 Participants
Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8
|
Treatment With Exposure/Response Prevention
n=40 Participants
Participants received exposure and response prevention therapy
Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.
Mean Y-BOCS score measured at week 8
|
Treatment With Pill Placebo
n=20 Participants
Participants received treatment with the placebo
Placebo : Placebo capsules will be identical in appearance to those of risperidone.
Mean Y-BOCS score measured at week 8
|
|---|---|---|---|
|
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form
QLESQ-SF Week 0
|
52.3 units on a scale
Standard Deviation 14.1
|
57.8 units on a scale
Standard Deviation 16.2
|
56.1 units on a scale
Standard Deviation 16.2
|
|
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form
QLESQ-SF Week 8
|
55.1 units on a scale
Standard Deviation 13.9
|
70.2 units on a scale
Standard Deviation 14.2
|
62.6 units on a scale
Standard Deviation 16.7
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Ham-D ranges from 0=no symptoms to 52 with higher numbers indicating more severe depression
Outcome measures
| Measure |
Treatment With Risperidone
n=40 Participants
Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8
|
Treatment With Exposure/Response Prevention
n=40 Participants
Participants received exposure and response prevention therapy
Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.
Mean Y-BOCS score measured at week 8
|
Treatment With Pill Placebo
n=20 Participants
Participants received treatment with the placebo
Placebo : Placebo capsules will be identical in appearance to those of risperidone.
Mean Y-BOCS score measured at week 8
|
|---|---|---|---|
|
Hamilton Depression Rating Scale (Ham-D)
Ham-D at Week 0
|
9.8 units on a scale
Standard Deviation 5.6
|
7.8 units on a scale
Standard Deviation 6.1
|
7.7 units on a scale
Standard Deviation 5.9
|
|
Hamilton Depression Rating Scale (Ham-D)
Ham-D at Week 8
|
8.0 units on a scale
Standard Deviation 5.7
|
7.8 units on a scale
Standard Deviation 6.1
|
7.7 units on a scale
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Scale ranges from 0 to 24 where 0 is "beliefs are false" and 24 is "convinced beliefs = reality"
Outcome measures
| Measure |
Treatment With Risperidone
n=40 Participants
Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8
|
Treatment With Exposure/Response Prevention
n=40 Participants
Participants received exposure and response prevention therapy
Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.
Mean Y-BOCS score measured at week 8
|
Treatment With Pill Placebo
n=20 Participants
Participants received treatment with the placebo
Placebo : Placebo capsules will be identical in appearance to those of risperidone.
Mean Y-BOCS score measured at week 8
|
|---|---|---|---|
|
Brown Assessment of Beliefs (BABS)
Week 0
|
5.7 units on a scale
Standard Deviation 4.0
|
6.1 units on a scale
Standard Deviation 4.6
|
5.3 units on a scale
Standard Deviation 3.8
|
|
Brown Assessment of Beliefs (BABS)
Week 8
|
4.5 units on a scale
Standard Deviation 4.2
|
2.4 units on a scale
Standard Deviation 2.9
|
4.3 units on a scale
Standard Deviation 3.3
|
Adverse Events
Treatment With Risperidone
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Treatment With Exposure/Response Prevention
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Treatment With Pill Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment With Risperidone
n=40 participants at risk
Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8
|
Treatment With Exposure/Response Prevention
n=40 participants at risk
Participants received exposure and response prevention therapy
Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.
Mean Y-BOCS score measured at week 8
|
Treatment With Pill Placebo
n=20 participants at risk
Participants received treatment with the placebo
Placebo : Placebo capsules will be identical in appearance to those of risperidone.
Mean Y-BOCS score measured at week 8
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
17.5%
7/40
|
22.5%
9/40
|
20.0%
4/20
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.5%
3/40
|
7.5%
3/40
|
10.0%
2/20
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/40
|
7.5%
3/40
|
10.0%
2/20
|
|
General disorders
Sweating
|
2.5%
1/40
|
10.0%
4/40
|
15.0%
3/20
|
|
Eye disorders
Photophobia
|
12.5%
5/40
|
7.5%
3/40
|
0.00%
0/20
|
|
Gastrointestinal disorders
Constipation
|
10.0%
4/40
|
0.00%
0/40
|
10.0%
2/20
|
|
Nervous system disorders
Lightheadedness
|
12.5%
5/40
|
15.0%
6/40
|
10.0%
2/20
|
|
Gastrointestinal disorders
Dry Mouth
|
25.0%
10/40
|
5.0%
2/40
|
25.0%
5/20
|
|
Eye disorders
Blurry Vision
|
12.5%
5/40
|
2.5%
1/40
|
10.0%
2/20
|
|
Reproductive system and breast disorders
Decreased Libido
|
22.5%
9/40
|
15.0%
6/40
|
5.0%
1/20
|
|
Reproductive system and breast disorders
Anorgasmia/Erectile Failure
|
15.0%
6/40
|
10.0%
4/40
|
0.00%
0/20
|
|
Nervous system disorders
Impaired Coordination
|
2.5%
1/40
|
2.5%
1/40
|
10.0%
2/20
|
|
Nervous system disorders
Fatigue
|
22.5%
9/40
|
20.0%
8/40
|
20.0%
4/20
|
|
Nervous system disorders
Nervousness
|
20.0%
8/40
|
15.0%
6/40
|
20.0%
4/20
|
|
Nervous system disorders
Insomnia
|
17.5%
7/40
|
12.5%
5/40
|
15.0%
3/20
|
|
Nervous system disorders
Tremor
|
0.00%
0/40
|
7.5%
3/40
|
15.0%
3/20
|
|
Gastrointestinal disorders
Weight Gain
|
32.5%
13/40
|
17.5%
7/40
|
10.0%
2/20
|
|
Gastrointestinal disorders
Weight Loss
|
7.5%
3/40
|
5.0%
2/40
|
5.0%
1/20
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
7.5%
3/40
|
0.00%
0/40
|
0.00%
0/20
|
|
Renal and urinary disorders
Urinary Dysfunction
|
7.5%
3/40
|
2.5%
1/40
|
5.0%
1/20
|
|
Reproductive system and breast disorders
Changes in breasts
|
7.5%
3/40
|
0.00%
0/40
|
0.00%
0/20
|
|
Gastrointestinal disorders
Increased thirst
|
15.0%
6/40
|
2.5%
1/40
|
20.0%
4/20
|
|
Nervous system disorders
Somnolence
|
17.5%
7/40
|
17.5%
7/40
|
20.0%
4/20
|
|
Nervous system disorders
Extrapyramidal symptoms
|
0.00%
0/40
|
0.00%
0/40
|
10.0%
2/20
|
Additional Information
Dr. Helen Blair Simpson
New York State Psychiatric Institute
Phone: 646-774-7000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place