Trial · NCT03348930
Tolcapone in Obsessive Compulsive Disorder
NCT03348930, Phase 2, Phase 3, Completed, University of Chicago; results first posted 2022-04-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tolcapone in Obsessive Compulsive Disorder. Trials, record NCT03348930. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03348930
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tolcapone in Obsessive Compulsive Disorder
- NCT number
- NCT03348930
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 20 participants, actual
- Lead sponsor
- University of Chicago
- Conditions
- Obsessive-Compulsive Disorder
- Interventions
- Tolcapone 200 MG
- First posted
- 2017-11-21
- Last updated
- 2022-04-07
- Results first posted
- 2022-04-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Yale Brown Obsessive Compulsive Scale (Y-BOCS) | 2 weeks (start of study to washout period OR two weeks following washout period) | The entire study for the subject will last 5 weeks. Every 2 weeks and after the one week washout period the subject will take the YBOCS. The change in scores from baseline to after 5 weeks will be assessed. The scale itself assesses severity of OCD symptoms. The YBOCS scale ranges from 0 to 40, with 0 being no symptoms and 40 being severe. |
| Secondary | Clinical Global Impression- Severity and Improvement (CGI) | 2 weeks (start of study to washout period OR two weeks following washout period) | The entire study for the subject will last 5 weeks. Every two weeks and after the one week washout period the subject will complete the CGI. The change in scores from baseline to after 5 weeks will be assessed. The scale itself assesses overall disorder severity on a scale from 1 to 7 with 1 being "not at all" and 7 being "among the most severe cases" |
| Secondary | Sheehan Disability Scale (SDS) | 2 weeks (start of study to washout period OR two weeks following washout period) | The entire study for the subject will last 5 weeks. Every two weeks and after the one week washout period the subject will complete the SDS. The change in scores from baseline to after 5 weeks will be assessed. The scale itself assesses the level of disability from obsessive compulsive disorder (or target disorder). The SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life. Work/school scores range from 0 to 10, Social life scores range from 0 to 10, Family life/home responsibilities scores range from 0 to 10). Total scores are calculated by adding the scores for work/school, social life, and family life. Total scores range from a minimum of 0 to a maximum of 30 (0 unimpaired, 30 highly impaired). |
| Secondary | Hamilton Anxiety Rating Scale (HAM-A) | 2 weeks (start of study to washout period OR two weeks following washout period) | Every study visit, the subject will complete the HAM-A. The change in scores from baseline to after 5 weeks will be assessed. The scale itself assesses level of anxiety. Higher scores indicate higher levels of anxiety, with 0 being no symptoms of anxiety and 30 being severe anxiety. |
| Secondary | Hamilton Depression Rating Scale (HAM-D) | 2 weeks (start of study to washout period OR two weeks following washout period) | The entire study for the subject will last 5 weeks. The HAM-D will be administered at every study visit. The change in scores from baseline to after the end of the 2-week active treatment period will be assessed and the change in scores from baseline to the end of the 2-week placebo period. The scale itself assesses level of depression. The minimum score is 0 and indicates no depressive symptoms, while the highest possible score is 50. Higher total scores indicate high levels of depression. Higher scores indicate a worse outcome. Higher total scored (14-50) indicate higher levels of depression, while a score between 0-7 is considered normal. |
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 | Yale Brown Obsessive Compulsive Scale (Y-BOCS) | 2 weeks (start of study to washout period OR two weeks following washout period) | All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis. | mean change in YBOCS score | MEAN |
| SECONDARY | Clinical Global Impression- Severity and Improvement (CGI) | 2 weeks (start of study to washout period OR two weeks following washout period) | Participants who fully completed Visits 2 and 4. | score on a scale | MEAN |
| SECONDARY | Sheehan Disability Scale (SDS) | 2 weeks (start of study to washout period OR two weeks following washout period) | Subjects who completed all five weeks of the study except for one subjects who's SDS data was missing at all time points (no data to carry forward). | mean change in SDS score | MEAN |
| SECONDARY | Hamilton Anxiety Rating Scale (HAM-A) | 2 weeks (start of study to washout period OR two weeks following washout period) | Adults with OCD who completed the study. | mean change in HAM-A score | MEAN |
| SECONDARY | Hamilton Depression Rating Scale (HAM-D) | 2 weeks (start of study to washout period OR two weeks following washout period) | Adults with OCD who completed the 5-week study. | mean change in HAM-D score | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Yale Brown Obsessive Compulsive Scale (Y-BOCS) | Tolcapone | -4.24 | Standard Deviation 6.20 | mean change in YBOCS score | |
| Yale Brown Obsessive Compulsive Scale (Y-BOCS) | Placebo | -1.10 | Standard Deviation 4.71 | mean change in YBOCS score | |
| Clinical Global Impression- Severity and Improvement (CGI) | Tolcapone | 3.78 | Standard Deviation 1.43 | score on a scale | |
| Clinical Global Impression- Severity and Improvement (CGI) | Placebo | 3.5 | Standard Deviation 0.90 | score on a scale | |
| Sheehan Disability Scale (SDS) | Tolcapone | -2.68 | Standard Deviation 4.41 | mean change in SDS score | |
| Sheehan Disability Scale (SDS) | Placebo | -1.97 | Standard Deviation 6.62 | mean change in SDS score | |
| Hamilton Anxiety Rating Scale (HAM-A) | Tolcapone | -1.90 | Standard Deviation 4.39 | mean change in HAM-A score | |
| Hamilton Anxiety Rating Scale (HAM-A) | Placebo | -1.60 | Standard Deviation 4.07 | mean change in HAM-A score | |
| Hamilton Depression Rating Scale (HAM-D) | Tolcapone | -1.65 | Standard Deviation 3.67 | mean change in HAM-D score | |
| Hamilton Depression Rating Scale (HAM-D) | Placebo | -2.00 | Standard Deviation 4.42 | mean change in HAM-D score |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (2 Weeks) | STARTED | Tolcapone, Then Placebo | 10 | |
| First Intervention (2 Weeks) | STARTED | Placebo, Then Tolcapone | 10 | |
| First Intervention (2 Weeks) | COMPLETED | Tolcapone, Then Placebo | 10 | |
| First Intervention (2 Weeks) | COMPLETED | Placebo, Then Tolcapone | 10 | |
| First Intervention (2 Weeks) | NOT COMPLETED | Tolcapone, Then Placebo | 0 | |
| First Intervention (2 Weeks) | NOT COMPLETED | Placebo, Then Tolcapone | 0 | |
| Washout (1 Week) | STARTED | Tolcapone, Then Placebo | 10 | |
| Washout (1 Week) | STARTED | Placebo, Then Tolcapone | 10 | |
| Washout (1 Week) | COMPLETED | Tolcapone, Then Placebo | 9 | |
| Washout (1 Week) | COMPLETED | Placebo, Then Tolcapone | 9 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events16
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 | Mild Headache | General disorders | Tolcapone | 1 | 20 | |
| other | Mild Headache | General disorders | Placebo | 0 | 20 | |
| other | Increased frequency in bowel movements | Gastrointestinal disorders | Tolcapone | 1 | 20 | |
| other | Increased frequency in bowel movements | Gastrointestinal disorders | Placebo | 0 | 20 | |
| other | Blood in stool | Gastrointestinal disorders | Tolcapone | 1 | 20 | |
| other | Blood in stool | Gastrointestinal disorders | Placebo | 0 | 20 | |
| other | Less frequent bowel movements | Gastrointestinal disorders | Tolcapone | 0 | 20 | |
| other | Less frequent bowel movements | Gastrointestinal disorders | Placebo | 1 | 20 | |
| other | Fatigue | General disorders | Tolcapone | 0 | 20 | |
| other | Fatigue | General disorders | Placebo | 1 | 20 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tolcapone | 0 | 20 |
| Total, all-cause mortality | Placebo | 0 | 20 |
| Total, other adverse events | Tolcapone | 3 | 20 |
| Total, other adverse events | Placebo | 5 | 20 |
| Total, serious adverse events | Tolcapone | 0 | 20 |
| Total, serious adverse events | Placebo | 0 | 20 |
Source ClinicalTrials.gov
Papers27
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tolcapone vs Placebo: deaths from any cause | Trial comparisons |
| Tolcapone vs Placebo: serious adverse events | Trial comparisons |
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/NCT03348930
GET https://conductscience.org/api/trials/v1/NCT03348930/papers?page=2