Trial Outcomes & Findings for Effects of Metformin and Fish Oil on Treatment With Clozapine (NCT NCT02140788)
NCT ID: NCT02140788
Last Updated: 2023-10-26
Results Overview
TERMINATED
PHASE4
34 participants
baseline, 2 weeks, 4 weeks
2023-10-26
Participant Flow
Thirty-four subjects were consented to the study; however, were never randomized. The study was terminated in Feb 2013 and no data was collected or analyzed.
Participant milestones
| Measure |
Metformin
Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.
Metformin
|
Fish Oil
Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.
Fish Oil
|
Metformin and Fish Oil
Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.
Metformin
Fish Oil
|
No Medication Added
Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Metformin and Fish Oil on Treatment With Clozapine
Baseline characteristics by cohort
| Measure |
All Subjects Who Consented
n=34 Participants
All subjects who signed a consent form
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 2 weeks, 4 weeksPopulation: Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 2 weeks, 4 weeksPopulation: Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 2 weeks, 4 weeksPopulation: Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 2 weeks, 4 weeksPopulation: Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 2 weeks, 4 weeksPopulation: Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.
The four positive items are: Suspiciousness, Unusual Thought Content, Hallucinations, Conceptual Disorganization.
Outcome measures
Outcome data not reported
Adverse Events
Metformin
Fish Oil
Metformin and Fish Oil
No Medication Added
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place