Trial Outcomes & Findings for Metformin for Weight Loss in Schizophrenia (NCT NCT01177709)

NCT ID: NCT01177709

Last Updated: 2017-09-01

Results Overview

Patients weight in pounds

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: baseline, 4 weeks, 8 weeks, 12 weeks
• Results posted on: 2017-09-01

Participant Flow

Participant milestones

Measure	Metformin Metformin: metformin 500- 2500 mg/day.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Metformin for Weight Loss in Schizophrenia

Baseline characteristics by cohort

Measure	Metformin n=12 Participants Metformin: metformin 500- 2500 mg/day.
Age, Continuous	38.5 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 4 weeks, 8 weeks, 12 weeks

Patients weight in pounds

Outcome measures

Measure	Metformin n=12 Participants Metformin: metformin 500- 2500 mg/day.
Weight (wt) in Pounds (Lbs).. baseline wt lbs	250.97 weight(wt) in pounds(lbs) Standard Error 11.52
Weight (wt) in Pounds (Lbs).. 4 week wt lbs	244.73 weight(wt) in pounds(lbs) Standard Error 10.84
Weight (wt) in Pounds (Lbs).. 8 week wt lbs	244.15 weight(wt) in pounds(lbs) Standard Error 10.06
Weight (wt) in Pounds (Lbs).. 12 week wt lbs	240.44 weight(wt) in pounds(lbs) Standard Error 9.22

SECONDARY outcome

Timeframe: baseline, 4 weeks, 8 weeks, 12 weeks

Fasting glucose

Outcome measures

Measure	Metformin n=12 Participants Metformin: metformin 500- 2500 mg/day.
Glucose Levels basline glucose	111.05 mg/dL Standard Error 12.83
Glucose Levels week 4 glucose	87.00 mg/dL Standard Error 2.95
Glucose Levels week 8 glucose	89.17 mg/dL Standard Error 2.17
Glucose Levels week 12 gluocse	94.25 mg/dL Standard Error 3.85

SECONDARY outcome

Timeframe: baseline, 4 weks, 8 weeks, 12 weeks

fasting serum insulin uIU/ml.

Outcome measures

Measure	Metformin n=12 Participants Metformin: metformin 500- 2500 mg/day.
Insulin Level baseline insulin	11.18 uIU/ml Standard Error 1.32
Insulin Level week 4 insulin	11.53 uIU/ml Standard Error 21.71
Insulin Level week 8 insulin	8.85 uIU/ml Standard Error 1.41
Insulin Level week 12 insulin	11.29 uIU/ml Standard Error 2.39

Adverse Events

Metformin

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Metformin n=12 participants at risk Metformin: metformin 500- 2500 mg/day.
Renal and urinary disorders low serum sodium,	8.3% 1/12 • Number of events 1
Respiratory, thoracic and mediastinal disorders penumonia	8.3% 1/12 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Robert C smith MD

Nathan Kline insistute for Psychiatric Research

Phone: 845-298-6531

Email: rsmith@nki.rfmh.org

Results disclosure agreements

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