Trial Outcomes & Findings for Tolcapone Treatment of Pathological Gambling (NCT NCT00927563)
NCT ID: NCT00927563
Last Updated: 2023-02-23
Results Overview
The overall impression of the clinician of the severity of the subject. Scores between 1 and 7 with 1 not being ill at all and 7 being one of the worst cases seen. CGI is assessed at every visit (1-5), but only the final visit will be reported here.
COMPLETED
PHASE2
24 participants
Visit 5 (final visit)
2023-02-23
Participant Flow
Subjects were recruited via media advertisement from January 2010 through February 2012 at the University of Minnesota Department of Psychiatry.
Subjects could not be using concomitant use of psychotropic medications with possible effects on PG symptoms (i.e. antidepressants, opioid antagonists)(due to possible interference of results) or have had previous treatment with tolcapone.
Participant milestones
| Measure |
Tolcapone
Tolcapone 100-300mg/day
Tolcapone : pill, 100-300mg/day for 8 weeks
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Tolcapone
Tolcapone 100-300mg/day
Tolcapone : pill, 100-300mg/day for 8 weeks
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Tolcapone Treatment of Pathological Gambling
Baseline characteristics by cohort
| Measure |
Tolcapone
n=24 Participants
Tolcapone 100-300mg/day
Tolcapone : pill, 100-300mg/day for 8 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
48.9 years
STANDARD_DEVIATION 12.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Visit 5 (final visit)The overall impression of the clinician of the severity of the subject. Scores between 1 and 7 with 1 not being ill at all and 7 being one of the worst cases seen. CGI is assessed at every visit (1-5), but only the final visit will be reported here.
Outcome measures
| Measure |
Tolcapone
n=22 Participants
Tolcapone 100-300mg/day
Tolcapone : pill, 100-300mg/day for 8 weeks
|
|---|---|
|
Clinical Global Impression Scale (CGI)
|
2.88 units on a scale
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: Visit 5 (final visit)Scale used to measure severity of gambling. Scores could range from 0-40 with 0 being the least severe and 40 being the most severe. Here the total score was used. The PG-YBOCS was completed at every visit (1-5), but the final visit (visit 5) will be the only score reported.
Outcome measures
| Measure |
Tolcapone
n=22 Participants
Tolcapone 100-300mg/day
Tolcapone : pill, 100-300mg/day for 8 weeks
|
|---|---|
|
Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS)
|
10.50 units on a scale
Standard Deviation 7.02
|
SECONDARY outcome
Timeframe: Visit 5 (final visit)Self report test of severity of gambling on a scale from 0-48 with 48 being the most severe. The G-SAS was performed at every visit (1-5), but only the final visit (visit 5) will be reported here as a final score.
Outcome measures
| Measure |
Tolcapone
n=22 Participants
Tolcapone 100-300mg/day
Tolcapone : pill, 100-300mg/day for 8 weeks
|
|---|---|
|
Gambling Symptom Assessment Scale (G-SAS)
|
18.67 units on a scale
Standard Deviation 10.58
|
Adverse Events
Tolcapone
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tolcapone
n=24 participants at risk
Tolcapone 100-300mg/day
Tolcapone : pill, 100-300mg/day for 8 weeks
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
3/24 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Dry Mouth
|
8.3%
2/24 • Number of events 2
|
|
Psychiatric disorders
Vivid Dreams
|
8.3%
2/24 • Number of events 2
|
|
Psychiatric disorders
Broken Sleep
|
4.2%
1/24 • Number of events 1
|
|
Metabolism and nutrition disorders
Increased Appetite
|
4.2%
1/24 • Number of events 1
|
|
Psychiatric disorders
Headache
|
4.2%
1/24 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place