Trial Outcomes & Findings for Tolcapone in Obsessive Compulsive Disorder (NCT NCT03348930)

NCT ID: NCT03348930

Last Updated: 2022-04-07

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 20 participants
• Primary outcome timeframe: 2 weeks (start of study to washout period OR two weeks following washout period)
• Results posted on: 2022-04-07

Participant Flow

Participant milestones

Measure	Tolcapone, Then Placebo Each subject will have a 2 week active treatment phase first with Tolcapone (100mg, twice a day), followed by a one-week washout period, followed by a 2 week treatment phase with a Tolcapone-matched placebo tablet.	Placebo, Then Tolcapone Each subject will have a 2 week active treatment phase first with a Tolcapone-matched placebo, followed by a one-week washout period, followed by a 2 week active treatment phase with Tolcapone (100mg, twice a day).
First Intervention (2 Weeks) STARTED	10	10
First Intervention (2 Weeks) COMPLETED	10	10
First Intervention (2 Weeks) NOT COMPLETED	0	0
Washout (1 Week) STARTED	10	10
Washout (1 Week) COMPLETED	9	9
Washout (1 Week) NOT COMPLETED	1	1
Second Intervention (2 Weeks) STARTED	9	9
Second Intervention (2 Weeks) COMPLETED	9	9
Second Intervention (2 Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Tolcapone, Then Placebo Each subject will have a 2 week active treatment phase first with Tolcapone (100mg, twice a day), followed by a one-week washout period, followed by a 2 week treatment phase with a Tolcapone-matched placebo tablet.	Placebo, Then Tolcapone Each subject will have a 2 week active treatment phase first with a Tolcapone-matched placebo, followed by a one-week washout period, followed by a 2 week active treatment phase with Tolcapone (100mg, twice a day).
Washout (1 Week) Lost to Follow-up	1	1

Baseline Characteristics

Tolcapone in Obsessive Compulsive Disorder

Baseline characteristics by cohort

Measure	Tolcapone/Placebo n=20 Participants Each subject will have a 4 week treatment phase with Tolcapone and a 4 week placebo phase before or after Tolcapone phase depending on randomization. Tolcapone 200 MG: All eligible study subjects will go through a 2-week treatment phase during which they will begin tolcapone at 100mg twice a day.
Age, Continuous	36.9 years STANDARD_DEVIATION 12.73 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	12 Participants n=5 Participants
Race/Ethnicity, Customized African American	4 Participants n=5 Participants
Race/Ethnicity, Customized Latino/Hispanic	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants
Any psychiatric comorbidity Yes	9 Participants n=5 Participants
Any psychiatric comorbidity No	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks (start of study to washout period OR two weeks following washout period)

Population: All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis.

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.

Outcome measures

Measure	Tolcapone n=19 Participants Tolcapone 200 MG: All eligible study subjects will go through a 2-week treatment phase (either during the first two weeks or last two weeks of the study) during which they will begin tolcapone at 100mg twice a day.	Placebo n=19 Participants All eligible study subjects will go through a 2-week phase (either during the first two weeks or last two weeks of the study) during which they will begin the tolcapone-matched placebo twice a day.
Yale Brown Obsessive Compulsive Scale (Y-BOCS)	-4.24 mean change in YBOCS score Standard Deviation 6.20	-1.10 mean change in YBOCS score Standard Deviation 4.71

SECONDARY outcome

Timeframe: 2 weeks (start of study to washout period OR two weeks following washout period)

Population: Participants who fully completed Visits 2 and 4.

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"

Outcome measures

Measure	Tolcapone n=17 Participants Tolcapone 200 MG: All eligible study subjects will go through a 2-week treatment phase (either during the first two weeks or last two weeks of the study) during which they will begin tolcapone at 100mg twice a day.	Placebo n=19 Participants All eligible study subjects will go through a 2-week phase (either during the first two weeks or last two weeks of the study) during which they will begin the tolcapone-matched placebo twice a day.
Clinical Global Impression- Severity and Improvement (CGI)	3.78 score on a scale Standard Deviation 1.43	3.5 score on a scale Standard Deviation 0.90

SECONDARY outcome

Timeframe: 2 weeks (start of study to washout period OR two weeks following washout period)

Population: 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).

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).

Outcome measures

Measure	Tolcapone n=18 Participants Tolcapone 200 MG: All eligible study subjects will go through a 2-week treatment phase (either during the first two weeks or last two weeks of the study) during which they will begin tolcapone at 100mg twice a day.	Placebo n=18 Participants All eligible study subjects will go through a 2-week phase (either during the first two weeks or last two weeks of the study) during which they will begin the tolcapone-matched placebo twice a day.
Sheehan Disability Scale (SDS)	-2.68 mean change in SDS score Standard Deviation 4.41	-1.97 mean change in SDS score Standard Deviation 6.62

SECONDARY outcome

Timeframe: 2 weeks (start of study to washout period OR two weeks following washout period)

Population: Adults with OCD who completed the study.

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.

Outcome measures

Measure	Tolcapone n=19 Participants Tolcapone 200 MG: All eligible study subjects will go through a 2-week treatment phase (either during the first two weeks or last two weeks of the study) during which they will begin tolcapone at 100mg twice a day.	Placebo n=19 Participants All eligible study subjects will go through a 2-week phase (either during the first two weeks or last two weeks of the study) during which they will begin the tolcapone-matched placebo twice a day.
Hamilton Anxiety Rating Scale (HAM-A)	-1.90 mean change in HAM-A score Standard Deviation 4.39	-1.60 mean change in HAM-A score Standard Deviation 4.07

SECONDARY outcome

Timeframe: 2 weeks (start of study to washout period OR two weeks following washout period)

Population: Adults with OCD who completed the 5-week study.

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.

Outcome measures

Measure	Tolcapone n=19 Participants Tolcapone 200 MG: All eligible study subjects will go through a 2-week treatment phase (either during the first two weeks or last two weeks of the study) during which they will begin tolcapone at 100mg twice a day.	Placebo n=19 Participants All eligible study subjects will go through a 2-week phase (either during the first two weeks or last two weeks of the study) during which they will begin the tolcapone-matched placebo twice a day.
Hamilton Depression Rating Scale (HAM-D)	-1.65 mean change in HAM-D score Standard Deviation 3.67	-2.00 mean change in HAM-D score Standard Deviation 4.42

Adverse Events

Tolcapone

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Tolcapone n=20 participants at risk Subjects received 100mg of tolcapone twice a day for two weeks either starting after the baseline visit, or starting after the 1-week washout period.	Placebo n=20 participants at risk Subjects received tolcapone-matched placebo twice a day for two weeks either starting after the baseline visit, or starting after the 1-week washout period.
General disorders Mild Headache	5.0% 1/20 • Adverse event data were collected through study completion, as necessary over the period of 5 week (the length of the trial).	0.00% 0/20 • Adverse event data were collected through study completion, as necessary over the period of 5 week (the length of the trial).
Gastrointestinal disorders Increased frequency in bowel movements	5.0% 1/20 • Adverse event data were collected through study completion, as necessary over the period of 5 week (the length of the trial).	0.00% 0/20 • Adverse event data were collected through study completion, as necessary over the period of 5 week (the length of the trial).
Gastrointestinal disorders Blood in stool	5.0% 1/20 • Adverse event data were collected through study completion, as necessary over the period of 5 week (the length of the trial).	0.00% 0/20 • Adverse event data were collected through study completion, as necessary over the period of 5 week (the length of the trial).
Gastrointestinal disorders Less frequent bowel movements	0.00% 0/20 • Adverse event data were collected through study completion, as necessary over the period of 5 week (the length of the trial).	5.0% 1/20 • Adverse event data were collected through study completion, as necessary over the period of 5 week (the length of the trial).
General disorders Fatigue	0.00% 0/20 • Adverse event data were collected through study completion, as necessary over the period of 5 week (the length of the trial).	5.0% 1/20 • Adverse event data were collected through study completion, as necessary over the period of 5 week (the length of the trial).
General disorders Muscle aching	0.00% 0/20 • Adverse event data were collected through study completion, as necessary over the period of 5 week (the length of the trial).	5.0% 1/20 • Adverse event data were collected through study completion, as necessary over the period of 5 week (the length of the trial).
General disorders Joint stiffness	0.00% 0/20 • Adverse event data were collected through study completion, as necessary over the period of 5 week (the length of the trial).	5.0% 1/20 • Adverse event data were collected through study completion, as necessary over the period of 5 week (the length of the trial).
General disorders Sleep problems	0.00% 0/20 • Adverse event data were collected through study completion, as necessary over the period of 5 week (the length of the trial).	5.0% 1/20 • Adverse event data were collected through study completion, as necessary over the period of 5 week (the length of the trial).

Additional Information

Dr. Jon Grant

University of Chicago

Phone: 7738341325

Email: jgrant4@bsd.uchicago.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place