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Catechol-O-Methyltransferase (COMT) Inhibitor
Tolcapone for Decision Making
Phase < 1
Waitlist Available
Led By Ming Hsu, PhD
Research Sponsored by University of California, Berkeley
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 weeks
Awards & highlights
Study Summary
This trial is investigating the relationship between social decision-making and dopamine levels in the brain, in order to better understand how this affects healthy and patient populations.
Who is the study for?
This trial is for right-handed individuals aged 18-40 with good general health and normal vision, who can consent to the study. It's not open to those on psychoactive meds, with a history of brain injury or psychiatric disorders, severe blood pressure issues, low IQ (<70), recent substance abuse (except nicotine), or major neurological conditions.Check my eligibility
What is being tested?
The study tests how dopamine affects social decision-making using Tolcapone (a medication) and fMRI scans. Participants will take Tolcapone and undergo brain imaging while performing tasks that measure their social decisions.See study design
What are the potential side effects?
Tolcapone may cause side effects like liver problems, muscle stiffness, confusion, fever; however specific side effects related to this trial are not listed but would be monitored by the research team.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Behavioral responses in neuroeconomic tasks
Blood oxygen level dependent (BOLD) activity
Side effects data
From 2018 Phase 4 trial • 95 Patients • NCT0104127418%
Weight increase
10%
Tachycardia
6%
Psychiatric Hospitalization
6%
Hypertension
6%
Loss of libido
4%
Concentration impaired
4%
Appetite increase
4%
Memory impaired
4%
Rash
4%
Restlessness
4%
Amenorrhea
2%
Drooling
2%
Anorgasmia
2%
Dizziness upon standing
2%
Drug abuse
2%
Sleep disturbed
2%
Apathy
2%
Blurred vision
2%
Akathisia
2%
Drug-related hospitalization
2%
Appetite decrease
2%
Cellulitis
2%
Hot flashes
2%
Medical Hospitalization
2%
Fatigue
2%
Hiccup
2%
Hit by a motorcycle
2%
Hurt when riding a bike
2%
Mental activity decreased
2%
Muscle twitch
2%
Sleeplessness
2%
Pneumonia
2%
Nightmares
2%
Teeth grating
2%
Incarceration
2%
Sensory hallucinations
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Citalopram
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TolcaponeExperimental Treatment2 Interventions
Tolcapone is a brain penetrant catechol-O-methyltransferase (COMT) inhibitor. It will be administered in a single 200mg dosage once in randomized, double-blind, counterbalanced fashion with a placebo.
Group II: PlaceboPlacebo Group1 Intervention
Placebo will be administered in a single pill once in randomized, double-blind, counterbalanced fashion with a placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tolcapone 200 MG
2019
Completed Phase 3
~90
Find a Location
Who is running the clinical trial?
Lawrence Berkeley National LaboratoryUNKNOWN
1 Previous Clinical Trials
3,179 Total Patients Enrolled
University of California, BerkeleyLead Sponsor
181 Previous Clinical Trials
720,940 Total Patients Enrolled
University of California, San FranciscoOTHER
2,517 Previous Clinical Trials
15,240,959 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a brain tumor, stroke, disease that damages the protective covering of nerve fibers, brain inflammation, or a burst blood vessel in the brain.You have tried to harm yourself in the past 5 years.You have a serious medical condition that needs to be treated.You are currently taking other medications for mental or neurological conditions on a regular basis.You have had a head injury in the past, ranging from mild to severe.You have been diagnosed with schizophrenia or other mental health disorders.You have been heavily drinking alcohol or have a problem with alcohol within the past month.You have been diagnosed with Alzheimer's disease or another major brain disorder that causes memory loss and thinking problems.You have had surgery on your brain that involved cutting into the brain tissue or have had a severe injury that penetrated the brain.
Research Study Groups:
This trial has the following groups:- Group 1: Tolcapone
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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