An interventional study of Risperidone and Exposure/ritual prevention therapy (EX/RP) in Obsessive-Compulsive Disorder, sponsored by New York State Psychiatric Institute. Completed at 2 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-04-25.
Sponsored by New York State Psychiatric Institute · Not applicable, Interventional, and Treatment
This study will compare the short- and long-term effectiveness of two common therapies in improving serotonin reuptake inhibitor treatment in people with obsessive-compulsive disorder.
Obsessive-compulsive disorder (OCD) is a common psychiatric illness. People with OCD experience unwelcome thoughts, known as obsessions, and feel compelled to perform repetitive behaviors, or compulsions. Impairment due to OCD symptoms ranges from mild to severe, and sometimes can be disabling. The only medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with SRI treatment, most patients continue to experience significant OCD symptoms, impaired functioning, and diminished quality of life. Cognitive-behavioral therapy (CBT), a talking therapy that focuses on altering a person's thoughts and behaviors, and the medication risperidone have both been commonly used for augmenting SRI treatment for OCD. This study will compare the short- and long-term effectiveness of exposure and ritual prevention (EX/RP), a type of CBT, and risperidone in augmenting SRI treatment in people with OCD.
Participants in this double-blind study will be randomly assigned to receive EX/RP, risperidone, or placebo in conjunction with their regular SRI medication. All participants will remain on their regular SRI at a stable dose. During the first 2 months of the study, 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. Participants assigned to risperidone or placebo will meet with a psychiatrist once every 1 to 2 weeks. At the end of 8 weeks, all participants' OCD symptom severity will be assessed. During this time, participants who have responded to treatment will continue receiving the same treatment for an additional 24 weeks. Participants assigned to EX/RP will meet with a therapist no more than 15 times total, and participants receiving risperidone or placebo will meet with a psychiatrist once every 4 weeks. Outcomes will be reassessed at study completion.
Ortho McNeil Janssen Scientific Affairs, LLC are providing medication and placebos for this study.
For information on a related study, please follow this link:
http://clinicaltrials.gov/show/NCT00045903
367 studies on the registry are indexed under Compulsive Personality Disorder; 67 are open to participants now.
This study's enrollment of 100 is above the median of 37 across 306 interventional studies indexed under Compulsive Personality Disorder.
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Exclusion Criteria:
Participants will receive treatment with risperidone
Drug: Risperidone
Participants will receive exposure and ritual prevention therapy (EX/RP)
Behavioral: Exposure/ritual prevention therapy (EX/RP)
Participants will receive treatment with the placebo
Drug: Placebo
Dosage of 0.5 mg to 4.0 mg per day as tolerated
Also known as: Risperdal
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.
Also known as: EX/RP
Placebo capsules will be identical in appearance to those of risperidone.
Also known as: PBO
Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Y-BOCS ranges from 0-40, with 0 meaning no symptoms and higher numbers meaning greater symptom severity
Time frame: Week 0 and Week 8
Social Adjustment Scale-SR
SAS-SR yields a mean score between 1 and 5; the higher the score, the more severe the social adjustment problems
Time frame: Week 0 and Week 8
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form
QLESQ ranges from 14-70, with higher scores meaning more enjoyment and satisfaction with quality of life
Time frame: Week 0 and Week 8
Hamilton Depression Rating Scale (Ham-D)
Ham-D ranges from 0=no symptoms to 52 with higher numbers indicating more severe depression
Time frame: Week 0 and Week 8
Brown Assessment of Beliefs (BABS)
Scale ranges from 0 to 24 where 0 is "beliefs are false" and 24 is "convinced beliefs = reality"
Time frame: Week 0 and Week 8
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.
| Milestone | Treatment With Risperidone | Treatment With Exposure/Response Prevention | Treatment With Pill Placebo |
|---|---|---|---|
| Started | 40 | 40 | 20 |
| Completed | 37 | 32 | 17 |
| Not completed | 3 | 8 | 3 |
Y-BOCS ranges from 0-40, with 0 meaning no symptoms and higher numbers meaning greater symptom severity
| units on a scale | Treatment With Risperidone | Treatment With Exposure/Response Prevention | Treatment With Pill Placebo |
|---|---|---|---|
| Y-BOCS score at Week 0 | 26.1 ± 4.3 | 27.2 ± 3.9 | 25.9 ± 4.6 |
| Y-BOCS score at Week 8 | 22.6 ± 8.8 | 13.0 ± 6.1 | 23.1 ± 6.9 |
SAS-SR yields a mean score between 1 and 5; the higher the score, the more severe the social adjustment problems
| units on a scale | Treatment With Risperidone | Treatment With Exposure/Response Prevention | Treatment With Pill Placebo |
|---|---|---|---|
| SAS-SR at Week 0 | 2.3 ± 0.4 | 2.3 ± 0.5 | 2.2 ± 0.7 |
| SAS-SR at Week 8 | 2.2 ± 0.4 | 1.9 ± 0.4 | 2.1 ± 0.5 |
QLESQ ranges from 14-70, with higher scores meaning more enjoyment and satisfaction with quality of life
| units on a scale | Treatment With Risperidone | Treatment With Exposure/Response Prevention | Treatment With Pill Placebo |
|---|---|---|---|
| QLESQ-SF Week 0 | 52.3 ± 14.1 | 57.8 ± 16.2 | 56.1 ± 16.2 |
| QLESQ-SF Week 8 | 55.1 ± 13.9 | 70.2 ± 14.2 | 62.6 ± 16.7 |
Ham-D ranges from 0=no symptoms to 52 with higher numbers indicating more severe depression
| units on a scale | Treatment With Risperidone | Treatment With Exposure/Response Prevention | Treatment With Pill Placebo |
|---|---|---|---|
| Ham-D at Week 0 | 9.8 ± 5.6 | 7.8 ± 6.1 | 7.7 ± 5.9 |
| Ham-D at Week 8 | 8.0 ± 5.7 | 7.8 ± 6.1 | 7.7 ± 5.9 |
Scale ranges from 0 to 24 where 0 is "beliefs are false" and 24 is "convinced beliefs = reality"
| units on a scale | Treatment With Risperidone | Treatment With Exposure/Response Prevention | Treatment With Pill Placebo |
|---|---|---|---|
| Week 0 | 5.7 ± 4.0 | 6.1 ± 4.6 | 5.3 ± 3.8 |
| Week 8 | 4.5 ± 4.2 | 2.4 ± 2.9 | 4.3 ± 3.3 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment With Risperidone | — | 0/40 (0%) | 30/40 (75%) |
| Treatment With Exposure/Response Prevention | — | 0/40 (0%) | 22/40 (55%) |
| Treatment With Pill Placebo | — | 0/20 (0%) | 13/20 (65%) |
| Event | Treatment With Risperidone | Treatment With Exposure/Response Prevention | Treatment With Pill Placebo |
|---|---|---|---|
| Weight GainGastrointestinal disorders | 13/40 | 7/40 | 2/20 |
| Dry MouthGastrointestinal disorders | 10/40 | 2/40 | 5/20 |
| HeadacheNervous system disorders | 7/40 | 9/40 | 4/20 |
| Decreased LibidoReproductive system and breast disorders | 9/40 | 6/40 | 1/20 |
| FatigueNervous system disorders | 9/40 | 8/40 | 4/20 |
| NervousnessNervous system disorders | 8/40 | 6/40 | 4/20 |
| Increased thirstGastrointestinal disorders | 6/40 | 1/40 | 4/20 |
| SomnolenceNervous system disorders | 7/40 | 7/40 | 4/20 |
| InsomniaNervous system disorders | 7/40 | 5/40 | 3/20 |
| SweatingGeneral disorders | 1/40 | 4/40 | 3/20 |
| Age, Categorical(Participants) | Treatment With Risperidone | Treatment With Exposure/Response Prevention | Treatment With Pill Placebo | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 40 | 40 | 20 | 100 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Treatment With Risperidone | Treatment With Exposure/Response Prevention | Treatment With Pill Placebo | Total |
|---|---|---|---|---|
| Mean | 33.8 ± 10.8 | 34.3 ± 12.7 | 33.4 ± 10.4 | 33.9 ± 11.4 |
| Sex: Female, Male(Participants) | Treatment With Risperidone | Treatment With Exposure/Response Prevention | Treatment With Pill Placebo | Total |
|---|---|---|---|---|
| Female | 21 | 21 | 6 | 48 |
| Male | 19 | 19 | 14 | 52 |
| Region of Enrollment(participants) | Treatment With Risperidone | Treatment With Exposure/Response Prevention | Treatment With Pill Placebo | Total |
|---|---|---|---|---|
| United States | 40 | 40 | 20 | 100 |
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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