Trial Outcomes & Findings for A Study of Neural Circuit Responses to Catechol-O-methyl Transferase (COMT) Inhibitors (NCT NCT01158950)

NCT ID: NCT01158950

Last Updated: 2020-11-20

Results Overview

The presented value represents a correlation. Subjects completed a delay discounting task while functional MRI images were obtained. In this task, subjects made hypothetical choices between a smaller amount of money available sooner, and a larger amount of money available later. Performance on the delay discounting task, as assessed by the impulsive choice ratio, was determined for both the tolcapone and placebo sessions, and the difference between them (tolcapone minus placebo) was calculated. This difference value was then correlated with baseline scores on the Barratt Impulsiveness Scale.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 26 participants
• Primary outcome timeframe: 120 minutes after drug ingestion
• Results posted on: 2020-11-20

Participant Flow

Subjects were screened for inclusion / exclusion criteria.

Participant milestones

Measure	Tolcapone First, Then Placebo Tolcapone 200mg (single dose) then Placebo (single dose) administered at study visit, followed by crossover to other drug at next visit	Placebo First, Then Tolcapone Placebo (single dose) then Tolcapone 200mg (single dose) tadministered at study visit, followed by crossover to other drug at next visit
1st Intervention (1 Day) STARTED	13	13
1st Intervention (1 Day) Data Collected	12	11
1st Intervention (1 Day) COMPLETED	12	11
1st Intervention (1 Day) NOT COMPLETED	1	2
Washout (1 Week) STARTED	12	11
Washout (1 Week) COMPLETED	12	11
Washout (1 Week) NOT COMPLETED	0	0
2nd Intervention (1 Day) STARTED	12	11
2nd Intervention (1 Day) COMPLETED	12	11
2nd Intervention (1 Day) NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Tolcapone First, Then Placebo Tolcapone 200mg (single dose) then Placebo (single dose) administered at study visit, followed by crossover to other drug at next visit	Placebo First, Then Tolcapone Placebo (single dose) then Tolcapone 200mg (single dose) tadministered at study visit, followed by crossover to other drug at next visit
1st Intervention (1 Day) Physician Decision	1	2

Baseline Characteristics

A Study of Neural Circuit Responses to Catechol-O-methyl Transferase (COMT) Inhibitors

Baseline characteristics by cohort

Measure	All Study Participants n=23 Participants All study participants receiving either Tolcapone 200mg (single dose) or Placebo (single dose) administered at study visit, followed by crossover to other drug at next visit - all participants were randomized to receive all interventions.
Age, Categorical <=18 years	0 Participants n=113 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=113 Participants
Age, Categorical >=65 years	0 Participants n=113 Participants
Age, Continuous	26.1 years STANDARD_DEVIATION 6.3 • n=113 Participants
Sex: Female, Male Female	13 Participants n=113 Participants
Sex: Female, Male Male	10 Participants n=113 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=113 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=113 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=113 Participants
Race (NIH/OMB) Asian	1 Participants n=113 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=113 Participants
Race (NIH/OMB) Black or African American	1 Participants n=113 Participants
Race (NIH/OMB) White	20 Participants n=113 Participants
Race (NIH/OMB) More than one race	1 Participants n=113 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants
Region of Enrollment United States	23 participants n=113 Participants
Barratt Impulsiveness Scale	58.6 units on a scale STANDARD_DEVIATION 9.1 • n=113 Participants

PRIMARY outcome

Timeframe: 120 minutes after drug ingestion

Population: The outcome for this study was the correlation between the baseline BIS score and the difference in ICR (tolcapone minus placebo). As such, one Arm/Group is presented below.

The presented value represents a correlation. Subjects completed a delay discounting task while functional MRI images were obtained. In this task, subjects made hypothetical choices between a smaller amount of money available sooner, and a larger amount of money available later. Performance on the delay discounting task, as assessed by the impulsive choice ratio, was determined for both the tolcapone and placebo sessions, and the difference between them (tolcapone minus placebo) was calculated. This difference value was then correlated with baseline scores on the Barratt Impulsiveness Scale.

Outcome measures

Measure

Functional MRI Arm (Tolcapone and Placebo) n=23 Participants This cognitive science study consists of a single arm in which all subjects receive both tolcapone and placebo in randomized, double-blind, counterbalanced, crossover fashion. Tolcapone is a medication in the class of catechol-O-methyltransferase (COMT) inhibitors. A placebo is a tablet or capsule that looks like the study medication (in this case, tolcapone) but does not contain any active ingredients.

Correlation Between the Impulsive Choice Ratio and Baseline Impulsivity, as Measured With the Barratt Impulsiveness Scale

-0.45 Correlation coefficient

OTHER_PRE_SPECIFIED outcome

Timeframe: 120 minutes after drug ingestion

Population: The outcome for this study was the correlation between the difference in the ICR and the difference in BOLD activity (tolcapone minus placebo). As such, one Arm / Group is presented below.

The presented value represents a correlation. The difference in performance on the delay discounting task was calculated as the change in ICR (tolcapone minus placebo). In addition, the difference in BOLD activity throughout the brain was determined (tolcapone minus placebo).

Outcome measures

Measure

Functional MRI Arm (Tolcapone and Placebo) n=23 Participants This cognitive science study consists of a single arm in which all subjects receive both tolcapone and placebo in randomized, double-blind, counterbalanced, crossover fashion. Tolcapone is a medication in the class of catechol-O-methyltransferase (COMT) inhibitors. A placebo is a tablet or capsule that looks like the study medication (in this case, tolcapone) but does not contain any active ingredients.

Correlation Between the Difference in ICR (Tolcapone Minus Placebo) and the Difference in Blood Oxygen Level Dependent (BOLD) Signal in the Brain (Tolcapone Minus Placebo)

-0.50 Correlation coefficient

Adverse Events

Tolcapone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jennifer Mitchell

University of California, San Francisco

Phone: 510-985-3522

Email: jennifer.mitchell@ucsf.edu

Results disclosure agreements

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