Obsessive-Compulsive Disorder
Conditions
Keywords
OCD, Augmentation, Antipsychotics, Cognitive-Behavioral Therapy
Brief summary
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.
Detailed description
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
Interventions
DRUGRisperidone
Dosage of 0.5 mg to 4.0 mg per day as tolerated
BEHAVIORALExposure/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.
DRUGPlacebo
Placebo capsules will be identical in appearance to those of risperidone.
Sponsors
National Institute of Mental Health (NIMH)
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Primary diagnosis of OCD * Currently on a stable and adequate dose of an SRI * Sufficient severity of symptoms to warrant additional augmentation treatment
Exclusion criteria
* Medical or psychiatric conditions that would make participation in the study unsafe * Currently receiving psychotherapy elsewhere at the time of study entry * Previously (within 12 weeks prior to study entry) attended 8 or more sessions of EX/RP within a 2-month period or received at least 4 weeks of antipsychotic augmentation while on an adequate SRI dose * Currently being treated with an SRI for the first time and has not yet responded, but has not tried another SRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | Week 0 and Week 8 | Y-BOCS ranges from 0-40, with 0 meaning no symptoms and higher numbers meaning greater symptom severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Social Adjustment Scale-SR | Week 0 and Week 8 | SAS-SR yields a mean score between 1 and 5; the higher the score, the more severe the social adjustment problems |
| Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form | Week 0 and Week 8 | QLESQ ranges from 14-70, with higher scores meaning more enjoyment and satisfaction with quality of life |
| Hamilton Depression Rating Scale (Ham-D) | Week 0 and Week 8 | Ham-D ranges from 0=no symptoms to 52 with higher numbers indicating more severe depression |
| Brown Assessment of Beliefs (BABS) | Week 0 and Week 8 | Scale ranges from 0 to 24 where 0 is beliefs are false and 24 is convinced beliefs = reality |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Treatment With Risperidone Participants will receive treatment with risperidone
Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated | 40 |
| 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. | 40 |
| Treatment With Pill Placebo Participants will receive treatment with the placebo
Placebo : Placebo capsules will be identical in appearance to those of risperidone. | 20 |
| Total | 100 |
Baseline characteristics
| Characteristic | Treatment With Exposure/Response Prevention | Treatment With Pill Placebo | Treatment With Risperidone | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 20 Participants | 40 Participants | 100 Participants |
| Age, Continuous | 34.3 years STANDARD_DEVIATION 12.7 | 33.4 years STANDARD_DEVIATION 10.4 | 33.8 years STANDARD_DEVIATION 10.8 | 33.9 years STANDARD_DEVIATION 11.4 |
| Region of Enrollment United States | 40 participants | 20 participants | 40 participants | 100 participants |
| Sex: Female, Male Female | 21 Participants | 6 Participants | 21 Participants | 48 Participants |
| Sex: Female, Male Male | 19 Participants | 14 Participants | 19 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 30 / 40 | 22 / 40 | 13 / 20 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 | 0 / 20 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment With Risperidone | 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 |
| Treatment With Risperidone | 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 |
| Treatment With Exposure/Response Prevention | Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | Y-BOCS score at Week 0 | 27.2 units on a scale | Standard Deviation 3.9 |
| Treatment With Exposure/Response Prevention | Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | Y-BOCS score at Week 8 | 13.0 units on a scale | Standard Deviation 6.1 |
| Treatment With Pill Placebo | Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | Y-BOCS score at Week 0 | 25.9 units on a scale | Standard Deviation 4.6 |
| Treatment With Pill Placebo | Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | Y-BOCS score at Week 8 | 23.1 units on a scale | Standard Deviation 6.9 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment With Risperidone | Brown Assessment of Beliefs (BABS) | Week 0 | 5.7 units on a scale | Standard Deviation 4 |
| Treatment With Risperidone | Brown Assessment of Beliefs (BABS) | Week 8 | 4.5 units on a scale | Standard Deviation 4.2 |
| Treatment With Exposure/Response Prevention | Brown Assessment of Beliefs (BABS) | Week 0 | 6.1 units on a scale | Standard Deviation 4.6 |
| Treatment With Exposure/Response Prevention | Brown Assessment of Beliefs (BABS) | Week 8 | 2.4 units on a scale | Standard Deviation 2.9 |
| Treatment With Pill Placebo | Brown Assessment of Beliefs (BABS) | Week 0 | 5.3 units on a scale | Standard Deviation 3.8 |
| Treatment With Pill Placebo | Brown Assessment of Beliefs (BABS) | Week 8 | 4.3 units on a scale | Standard Deviation 3.3 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment With Risperidone | Hamilton Depression Rating Scale (Ham-D) | Ham-D at Week 0 | 9.8 units on a scale | Standard Deviation 5.6 |
| Treatment With Risperidone | Hamilton Depression Rating Scale (Ham-D) | Ham-D at Week 8 | 8.0 units on a scale | Standard Deviation 5.7 |
| Treatment With Exposure/Response Prevention | Hamilton Depression Rating Scale (Ham-D) | Ham-D at Week 0 | 7.8 units on a scale | Standard Deviation 6.1 |
| Treatment With Exposure/Response Prevention | Hamilton Depression Rating Scale (Ham-D) | Ham-D at Week 8 | 7.8 units on a scale | Standard Deviation 6.1 |
| Treatment With Pill Placebo | Hamilton Depression Rating Scale (Ham-D) | Ham-D at Week 0 | 7.7 units on a scale | Standard Deviation 5.9 |
| Treatment With Pill Placebo | Hamilton Depression Rating Scale (Ham-D) | Ham-D at Week 8 | 7.7 units on a scale | Standard Deviation 5.9 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment With Risperidone | Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form | QLESQ-SF Week 0 | 52.3 units on a scale | Standard Deviation 14.1 |
| Treatment With Risperidone | Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form | QLESQ-SF Week 8 | 55.1 units on a scale | Standard Deviation 13.9 |
| Treatment With Exposure/Response Prevention | Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form | QLESQ-SF Week 0 | 57.8 units on a scale | Standard Deviation 16.2 |
| Treatment With Exposure/Response Prevention | Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form | QLESQ-SF Week 8 | 70.2 units on a scale | Standard Deviation 14.2 |
| Treatment With Pill Placebo | Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form | QLESQ-SF Week 0 | 56.1 units on a scale | Standard Deviation 16.2 |
| Treatment With Pill Placebo | Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form | QLESQ-SF Week 8 | 62.6 units on a scale | Standard Deviation 16.7 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment With Risperidone | Social Adjustment Scale-SR | SAS-SR at Week 0 | 2.3 units on a scale | Standard Deviation 0.4 |
| Treatment With Risperidone | Social Adjustment Scale-SR | SAS-SR at Week 8 | 2.2 units on a scale | Standard Deviation 0.4 |
| Treatment With Exposure/Response Prevention | Social Adjustment Scale-SR | SAS-SR at Week 0 | 2.3 units on a scale | Standard Deviation 0.5 |
| Treatment With Exposure/Response Prevention | Social Adjustment Scale-SR | SAS-SR at Week 8 | 1.9 units on a scale | Standard Deviation 0.4 |
| Treatment With Pill Placebo | Social Adjustment Scale-SR | SAS-SR at Week 0 | 2.2 units on a scale | Standard Deviation 0.7 |
| Treatment With Pill Placebo | Social Adjustment Scale-SR | SAS-SR at Week 8 | 2.1 units on a scale | Standard Deviation 0.5 |