Trial Outcomes & Findings for The Use of Metformin in the Treatment of Antipsychotic-Induced Weight Gain in Schizophrenia (The METS Study) (NCT NCT00816907)

Results Overview

Mean difference in body weight change between participants assigned to metformin and participants assigned to placebo from baseline to last study visit (up to 16 weeks)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

146 participants

Primary outcome timeframe

Measured at the last study visit

Results posted on

2013-03-27

Participant Flow

A randomized, double-blind, placebo-controlled multicenter trial conducted between March 2009 and February 2010 at 17 academic, veterans affairs, and private research clinics. 146 clinically stable overweight outpatients with chronic schizophrenia and schizoaffective disorder were enrolled.

Prior to randomization prospective participants were screened for eligibility

Participant milestones

Participant milestones
Measure	Placebo Matching over-encapsulated placebo pills	Metformin Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
Overall Study STARTED	71	75
Overall Study COMPLETED	58	58
Overall Study NOT COMPLETED	13	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Use of Metformin in the Treatment of Antipsychotic-Induced Weight Gain in Schizophrenia (The METS Study)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=71 Participants Matching over-encapsulated placebo pills	Metformin n=75 Participants Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated	Total n=146 Participants Total of all reporting groups
Age Continuous	45.0 years STANDARD_DEVIATION 10.3 • n=5 Participants	41.4 years STANDARD_DEVIATION 11.5 • n=7 Participants	43.2 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	52 Participants n=7 Participants	101 Participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at the last study visit

Population: Evaluable population that took assigned study treatment

Mean difference in body weight change between participants assigned to metformin and participants assigned to placebo from baseline to last study visit (up to 16 weeks)

Outcome measures

Outcome measures
Measure	Placebo n=71 Participants Matching over-encapsulated placebo pills	Metformin n=75 Participants Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
Mean Difference in Body Weight Change Between Participants Assigned to Metformin and Participants Assigned to Placebo	-1.0 kilograms Interval -2.0 to 0.0	-3.0 kilograms Interval -4.0 to -2.0

SECONDARY outcome

Timeframe: 16 weeks

Population: randomized participants who took assigned treatment

Total cholesterol

Outcome measures

Outcome measures
Measure	Placebo n=71 Participants Matching over-encapsulated placebo pills	Metformin n=75 Participants Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
Change in Total Cholesterol From Baseline to 16 Weeks	0.2 mg/dL Interval -6.5 to 6.9	-8.9 mg/dL Interval -15.6 to -2.3

SECONDARY outcome

Timeframe: 16 weeks

Population: randomized participants who took assigned treatment

high-density lipoprotein