Trial · NCT00389493
Risperidone or Cognitive-Behavioral Therapy for Improving Medication Treatment for Obsessive-compulsive Disorder
NCT00389493, Not applicable, Completed, New York State Psychiatric Institute; results first posted 2014-04-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Risperidone or Cognitive-Behavioral Therapy for Improving Medication Treatment for Obsessive-compulsive Disorder. Trials, record NCT00389493. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00389493
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Risperidone or Cognitive-Behavioral Therapy for Improving Medication Treatment for Obsessive-compulsive Disorder
- NCT number
- NCT00389493
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 100 participants, actual
- Lead sponsor
- New York State Psychiatric Institute
- Conditions
- Obsessive-Compulsive Disorder
- Interventions
- Risperidone, Exposure/ritual prevention therapy (EX/RP), Placebo
- First posted
- 2006-10-18
- Last updated
- 2014-04-25
- Results first posted
- 2014-04-25
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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 |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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" |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | Week 0 and Week 8 | units on a scale | MEAN | |
| SECONDARY | Social Adjustment Scale-SR | Week 0 and Week 8 | units on a scale | MEAN | |
| SECONDARY | Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form | Week 0 and Week 8 | units on a scale | MEAN | |
| SECONDARY | Hamilton Depression Rating Scale (Ham-D) | Week 0 and Week 8 | units on a scale | MEAN | |
| SECONDARY | Brown Assessment of Beliefs (BABS) | Week 0 and Week 8 | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | Treatment With Risperidone | Y-BOCS score at Week 0 | 26.1 | Standard Deviation 4.3 | units on a scale |
| Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | Treatment With Exposure/Response Prevention | Y-BOCS score at Week 0 | 27.2 | Standard Deviation 3.9 | units on a scale |
| Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | Treatment With Pill Placebo | Y-BOCS score at Week 0 | 25.9 | Standard Deviation 4.6 | units on a scale |
| Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | Treatment With Risperidone | Y-BOCS score at Week 8 | 22.6 | Standard Deviation 8.8 | units on a scale |
| Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | Treatment With Exposure/Response Prevention | Y-BOCS score at Week 8 | 13.0 | Standard Deviation 6.1 | units on a scale |
| Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | Treatment With Pill Placebo | Y-BOCS score at Week 8 | 23.1 | Standard Deviation 6.9 | units on a scale |
| Social Adjustment Scale-SR | Treatment With Risperidone | SAS-SR at Week 0 | 2.3 | Standard Deviation 0.4 | units on a scale |
| Social Adjustment Scale-SR | Treatment With Exposure/Response Prevention | SAS-SR at Week 0 | 2.3 | Standard Deviation 0.5 | units on a scale |
| Social Adjustment Scale-SR | Treatment With Pill Placebo | SAS-SR at Week 0 | 2.2 | Standard Deviation 0.7 | units on a scale |
| Social Adjustment Scale-SR | Treatment With Risperidone | SAS-SR at Week 8 | 2.2 | Standard Deviation 0.4 | units on a scale |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment With Risperidone | 40 | |
| Overall Study | STARTED | Treatment With Exposure/Response Prevention | 40 | |
| Overall Study | STARTED | Treatment With Pill Placebo | 20 | |
| Overall Study | COMPLETED | Treatment With Risperidone | 37 | |
| Overall Study | COMPLETED | Treatment With Exposure/Response Prevention | 32 | |
| Overall Study | COMPLETED | Treatment With Pill Placebo | 17 | |
| Overall Study | NOT COMPLETED | Treatment With Risperidone | 3 | |
| Overall Study | NOT COMPLETED | Treatment With Exposure/Response Prevention | 8 | |
| Overall Study | NOT COMPLETED | Treatment With Pill Placebo | 3 |
Source ClinicalTrials.gov
Adverse events72
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Treatment With Risperidone | 7 | 40 | |
| other | Headache | Nervous system disorders | Treatment With Exposure/Response Prevention | 9 | 40 | |
| other | Headache | Nervous system disorders | Treatment With Pill Placebo | 4 | 20 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Treatment With Risperidone | 3 | 40 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Treatment With Exposure/Response Prevention | 3 | 40 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Treatment With Pill Placebo | 2 | 20 | |
| other | Nausea | Gastrointestinal disorders | Treatment With Risperidone | 0 | 40 | |
| other | Nausea | Gastrointestinal disorders | Treatment With Exposure/Response Prevention | 3 | 40 | |
| other | Nausea | Gastrointestinal disorders | Treatment With Pill Placebo | 2 | 20 | |
| other | Sweating | General disorders | Treatment With Risperidone | 1 | 40 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment With Risperidone | ||
| Total, all-cause mortality | Treatment With Exposure/Response Prevention | ||
| Total, all-cause mortality | Treatment With Pill Placebo | ||
| Total, other adverse events | Treatment With Risperidone | 30 | 40 |
| Total, other adverse events | Treatment With Exposure/Response Prevention | 22 | 40 |
| Total, other adverse events | Treatment With Pill Placebo | 13 | 20 |
| Total, serious adverse events | Treatment With Risperidone | 0 | 40 |
| Total, serious adverse events | Treatment With Exposure/Response Prevention | 0 | 40 |
| Total, serious adverse events | Treatment With Pill Placebo | 0 | 20 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01MH045404 | 2/2-- Attaining and Maintaining Wellness in OCD | FOA, EDNA B | UNIVERSITY OF PENNSYLVANIA | NATIONAL INSTITUTE OF MENTAL HEALTH | 1990 to 2016 | NIH RePORTER |
| R01MH045436 | 1/2-Attaining and Maintaining Wellness in OCD | SIMPSON, HELEN BLAIR | NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC | NATIONAL INSTITUTE OF MENTAL HEALTH | 1990 to 2015 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00389493
GET https://conductscience.org/api/trials/v1/NCT00389493/results?page=2