Metformin for Weight Loss in Schizophrenia

NCT ID: NCT01177709

Last Updated: 2017-09-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2011-04-30

Brief Summary

Study hypothesis is that patients on antipsychotics medication treated with metformin will show loss in weight and improved measures of glucose metabolism.

Detailed Description

Patients who had gained more than 10 lbs of weight in the last 3 months or had BMI of 35 or greater were treated with metformin up to 2500 mg/day in an open label study of up to 3 months time. Changes in weight and glucose measures were recorded.

Conditions

Schizophrenia; Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metformin

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

metformin 500- 2500 mg/day. Patient received variable doses of metformin starting at 500 mg/day and increasing up to maximum of 2500 mg/day over 3-4 weeks. Dose was titrated on tolerability and side effects, especially development of hypoglycemia. This explains why different patients received different maximum doses.

Interventions

Metformin

metformin 500- 2500 mg/day. Patient received variable doses of metformin starting at 500 mg/day and increasing up to maximum of 2500 mg/day over 3-4 weeks. Dose was titrated on tolerability and side effects, especially development of hypoglycemia. This explains why different patients received different maximum doses.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients will be 18-70 years of age;
• Currently hospitalized or an outpatient at MPC;
• BMI ≥ 35 or excessive recent weight gain ( > than 10 lb weight gain in the past 3 months);
• Patients will have a diagnosis of schizophrenia or schizoaffective disorder or bipolar disorder.

Exclusion Criteria

• Age below 18 or over 70;
• Patient is currently already treated with metformin.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nathan Kline Institute for Psychiatric Research

OTHER

Sponsor Role: lead

Responsible Party

Robert C. Smith MD PhD

Research Psychiatrist-Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert C. Smith, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Nathan Kline Institute for Psychiatric Research

Locations

Manhatan Psychiatric Center

New York, New York, United States

Countries

United States

Other Identifiers

091/C22

Identifier Type: -

Identifier Source: org_study_id