Metformin for Weight Loss in Schizophrenia

NCT01177709 | Terminated Results

• 1 other identifier: 091/C22
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia; Obesity

Keywords

schizophrenia; antipsychotics; obesity; diabetes

Outcome Measures

Primary Outcomes (1)

• Weight (wt) in Pounds (Lbs)..

  Patients weight in pounds

  baseline, 4 weeks, 8 weeks, 12 weeks

Secondary Outcomes (2)

• Glucose Levels

  baseline, 4 weeks, 8 weeks, 12 weeks

• Insulin Level

  baseline, 4 weks, 8 weeks, 12 weeks

Study Arms (1)

Metformin

EXPERIMENTAL

Drug: Metformin

Interventions

Metformin 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.

Metformin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nathan Kline Institute for Psychiatric Research: lead

Study Sites (1)

Manhatan Psychiatric Center

New York, New York, 10035, United States

Location

MeSH Terms

Conditions

Schizophrenia; Obesity; Diabetes Mellitus

Interventions

Metformin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Limitations and Caveats

This is an open non-blinded study in a small number of subjects. However, it is unlikely that outcomes measures of weight, glucose, and insulin, would have been likely to be affected by non-blinding of subjects and investigators. .

Results Point of Contact

• Title: Robert C smith MD
• Organization: Nathan Kline insistute for Psychiatric Research

rsmith@nki.rfmh.org

845-298-6531

Study Officials

• Robert C. Smith, MD PHD

  Nathan Kline Institute for Psychiatric Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist-Principal investigator

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: August 9, 2010
• Study Start: May 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: September 1, 2017
• Results First Posted: February 7, 2017

Record last verified: 2017-08

Locations

US (1)