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SchizophreniaPhase 4METSNCT00816907

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

A Phase 4 study testing Metformin in people with Schizophrenia, run by National Institute of Mental Health (NIMH) at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will test the usefulness of the medication metformin in treating people with schizophrenia or schizoaffective disorder who are overweight and also taking antipsychotic medications. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
146 participants
Where
16 sitesUnited States
Study dates
Jan 2009to Mar 2010
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Outpatients with a diagnosis of schizophrenia or schizoaffective disorder, as defined by DSM-IV-TR criteria and confirmed by the Structured Clinical Interview for DSM-IV (SCID)
  • Duration of illness greater than 1 year, as defined by having initiated antipsychotic treatment at least 1 year prior to study entry
  • Adequate decisional capacity to make a choice about participating in this research study
  • Body mass index (BMI) at or greater than 27
  • Currently being treated with one or a combination of two antipsychotic medications (typical or atypical) and on that drug regimen for at least 2 months prior to study entry, with stable dosages for at least 1 month
  • If taking antidepressants, mood stabilizers, or anxiolytics, the dose must be stable for at least 1 month prior to study entry
  • Willing to use an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study. Acceptable methods include oral, injectable, or implanted contraceptives; intrauterine devices or barrier methods such as condoms; and diaphragms and spermicides.

Who cannot join

  • Inpatient status
  • Clinical Global Impression Severity (CGI-S) score greater than 6
  • Currently being treated with more than two antipsychotic medications
  • Fasting glucose greater than 125
  • Diagnosis of diabetes mellitus or treatment with insulin or oral hypoglycemics
  • Previous or current treatment with metformin
Show all 18Show fewer
  • Diagnosis of congestive heart failure
  • Renal impairment, as defined by a serum creatinine level greater than 1.5 in males or greater than 1.4 in females, or creatinine estimated glomerular filtration rate (GFR) outside of normal limits
  • Hepatic disease, as defined by aspartate transaminase (AST), alanine transaminase (ALT), or c-glutamyl transferase (CGT) greater than 1.5 times upper limit of normal (ULN), or total bilirubin greater than 1.2 times ULN
  • Metabolic acidosis, as defined by serum carbon dioxide less than the lower limit of normal
  • Known hypersensitivity to metformin
  • Pregnant or breastfeeding
  • Recent (in the past 30 days) or scheduled radiological studies involving iodinated contrast material
  • Alcohol abuse or dependence within the past month, as determined by the SCID
  • Other serious and unstable medical condition in the judgment of the investigator
  • Diagnosis of mental retardation, delirium, or dementia, as defined by DSM-IV-TR
  • Failed to discontinue 4 weeks prior to study entry any medication used for weight loss
  • Concurrent treatment with certain drugs that are known to increase metformin blood levels should be discussed with the Project Medical Officer.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • New Mexico VA Healthcare System

    Albuquerque, New Mexico, 87108

  • Mental Health Advocates

    Boca Raton, Florida, 33431

  • Freedom Trail Clinic

    Boston, Massachusetts, 02114

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75235

  • Clinical Insights

    Glen Burnie, Maryland, 21061

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Iowa

    Iowa City, Iowa, 52242

  • University of Minnesota School of Medicine

    Minneapolis, Minnesota, 55454

  • Vanderbilt University Schizophrenia Research

    Nashville, Tennessee, 37212

  • Research Foundation for Mental Hygiene

    New York, New York, 10032

  • Stanford University

    Palo Alto, California, 94305

  • University of Rochester

    Rochester, New York, 14623

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Clinical Research Institute

    Wichita, Kansas, 67207

  • University of Massachusetts

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: Metformin in the Treatment of Antipsychotic-Induced Weight Gain in Schizophrenia (METS) - Pilot Study

This study will test the usefulness of the medication metformin in treating people with schizophrenia or schizoaffective disorder who are overweight and also taking antipsychotic medications.

Read the detailed description

Schizophrenia is a chronic mental disorder that is characterized, in part, by psychotic symptoms. Psychotic symptoms include hallucinations and delusions, in which a person has abnormal experiences or beliefs, and are commonly treated with antipsychotic medications. Unfortunately, a side effect of many antipsychotics is unwanted weight gain, which can lead to physical illness. Use of the drug metformin has resulted in weight loss among diabetics. Metformin has also been shown to cause weight loss in preliminary studies of people taking atypical antipsychotics-a newer, second generation of antipsychotic medications. Metformin is currently approved by the Food and Drug Administration to treat only people with diabetes. This study will test the usefulness of prescribing metformin as a second medication to treat people with schizophrenia or schizoaffective disorder who are overweight and taking antipsychotics. The study will also provide important feasibility information for future larger studies.

Participation in this study will last 16 weeks. After undergoing baseline assessments, participants will be randomly assigned to receive either metformin or placebo, both of which will be taken twice daily for the duration of the study. All participants will also receive behavioral therapy that will teach them about reducing their weight through diet and exercise. Participants will undergo assessments at 11 study visits: the first 2 will include screening and baseline testing, the next 2 visits will take place after the first and second weeks of receiving treatment, and the last 7 visits will take place every 2 weeks until the end of the study. Assessments will include measurements of body weight, waist-to-hip ratio, and vital signs; clinical interviews about medication adherence, side effects, and alcohol use; and monthly blood tests to assess levels of lipids, glucose, insulin, and hemoglobin A1c.

Conditions
Schizophrenia
Being tested
Metformin, Placebo
Keywords
Schizoaffective Disorder
Medical subject headings
Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetforminDrug

    Also called Glucophage

    500 mg to 1,000 mg taken twice daily for 16 weeks

  • PlaceboDrug

    1 to 2 placebo capsules taken twice daily for 16 weeks

Study groups in NCT00816907
Study groupRoleWhat they receive
MetforminExperimentalEncapsulated metformin 1000-2000 mg/day
Receives: Drug: Metformin
PlaceboPlacebo comparatorMatching placebo capsules 2-4 daily
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Difference in Body Weight Change Between Participants Assigned to Metformin and Participants Assigned to Placebo

    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)

    Measured: Measured at the last study visit

Secondary outcomes (7)

  1. Change in Total Cholesterol From Baseline to 16 Weeks

    Total cholesterol

    Measured: 16 weeks

  2. Change in HDL Cholesterol From Baseline to 16 Weeks

    high-density lipoprotein

    Measured: 16 weeks

  3. Change in LDL Cholesterol From Baseline to 16 Weeks

    low-density lipoprotein

    Measured: 16 weeks

  4. Change in Triglycerides From Baseline to 16 Weeks

    serum triglycerides

    Measured: 16 weeks

  5. Change in Fasting Glucose From Baseline to 16 Weeks

    fasting blood glucose

    Measured: 16 weeks

  6. Change in Fasting Insulin From Baseline to 16 Weeks

    Fasting insulin

    Measured: 16 weeks

  7. Change in Hemoglobin A1c From Baseline to 16 Weeks

    glycosylated hemoglobin

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionFeb 2010
  4. Study completionMar 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00816907
Sponsor's protocol ID
N01 MH090001-03
Other IDs
N01MH90001 DSIR AT, N01MH90001, N01MH090001
Acronym
METS
Status last verified
Nov 2010
First submitted
2 Jan 2009
Last updated
27 Mar 2013
Data monitoring committee
Yes

Publications

  • Wang B, Ogburn EL, Rosenblum M. Analysis of covariance in randomized trials: More precision and valid confidence intervals, without model assumptions. Biometrics. 2019 Dec;75(4):1391-1400. doi: 10.1111/biom.13062. Epub 2019 Jun 3.

    PubMed 31009064

  • Jarskog LF, Hamer RM, Catellier DJ, Stewart DD, Lavange L, Ray N, Golden LH, Lieberman JA, Stroup TS; METS Investigators. Metformin for weight loss and metabolic control in overweight outpatients with schizophrenia and schizoaffective disorder. Am J Psychiatry. 2013 Sep;170(9):1032-40. doi: 10.1176/appi.ajp.2013.12010127.

    PubMed 23846733

  • Khan AY, Macaluso M, McHale RJ, Dahmen MM, Girrens K, Ali F. The adjunctive use of metformin to treat or prevent atypical antipsychotic-induced weight gain: a review. J Psychiatr Pract. 2010 Sep;16(5):289-96. doi: 10.1097/01.pra.0000388624.91039.a3.

    PubMed 20859106

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metformin in people with Schizophrenia, run by National Institute of Mental Health (NIMH) at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Difference in Body Weight Change Between Participants Assigned to Metformin and Participants Assigned to Placebo (time frame: Measured at the last study visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00816907, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2013.

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