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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

National Institute of Mental Health (NIMH)

ClinicalTrials.gov Identifier:

NCT00816907

First received: January 2, 2009

Last updated: February 13, 2013

Last verified: November 2010

History of Changes

Results First Received: January 3, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Schizophrenia
Interventions:	Drug: Metformin Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to randomization prospective participants were screened for eligibility

Reporting Groups

	Description
Placebo	Matching over-encapsulated placebo pills
Metformin	Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated

Participant Flow: Overall Study

	Placebo	Metformin
STARTED	71	75
COMPLETED	58	58
NOT COMPLETED	13	17

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Placebo	Matching over-encapsulated placebo pills
Metformin	Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
Total	Total of all reporting groups

Baseline Measures

	Placebo	Metformin	Total
Number of Participants [units: participants]	71	75	146
Age [units: years] Mean (Standard Deviation)	45.0 (10.3)	41.4 (11.5)	43.2 (11.1)
Gender [units: participants]
Female	22	23	45
Male	49	52	101

Outcome Measures

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1. Primary:

Mean Difference in Body Weight Change Between Participants Assigned to Metformin and Participants Assigned to Placebo [ Time Frame: Measured at the last study visit ]

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Measure Type	Primary
Measure Title	Mean Difference in Body Weight Change Between Participants Assigned to Metformin and Participants Assigned to Placebo
Measure Description	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)
Time Frame	Measured at the last study visit
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable population that took assigned study treatment

Reporting Groups

	Description
Placebo	Matching over-encapsulated placebo pills
Metformin	Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated

Measured Values

	Placebo	Metformin
Number of Participants Analyzed [units: participants]	71	75
Mean Difference in Body Weight Change Between Participants Assigned to Metformin and Participants Assigned to Placebo [units: kilograms] Mean (95% Confidence Interval)	-1.0 (-2.0 to -0.0)	-3.0 (-4.0 to -2.0)

No statistical analysis provided for Mean Difference in Body Weight Change Between Participants Assigned to Metformin and Participants Assigned to Placebo

2. Secondary:

Change in Total Cholesterol From Baseline to 16 Weeks [ Time Frame: 16 weeks ]

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Measure Type	Secondary
Measure Title	Change in Total Cholesterol From Baseline to 16 Weeks
Measure Description	Total cholesterol
Time Frame	16 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
randomized participants who took assigned treatment

Reporting Groups

	Description
Placebo	No text entered.
Metformin	No text entered.

Measured Values

	Placebo	Metformin
Number of Participants Analyzed [units: participants]	71	75
Change in Total Cholesterol From Baseline to 16 Weeks [units: mg/dL] Mean (95% Confidence Interval)	0.2 (-6.5 to 6.9)	-8.9 (-15.6 to -2.3)