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Effects of Metformin and Fish Oil on Treatment With Clozapine

NCT02140788 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-10-26

Study results available
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Summary

One purpose of this study is to test whether adding metformin will limit some of the unwanted effects of clozapine, compared to not adding metformin. Metformin is a medication that is approved by the United States Food and Drug Administration (FDA) for the treatment of type-2 diabetes. Studies have found that people with type-2 diabetes often lose some weight when they take metformin, however the FDA has not approved metformin for weight loss, so for this study the use of metformin is investigational. This study will test whether metformin can help people with schizophrenia or schizoaffective disorders lose weight.

Another purpose of this study is to test whether adding fish oil will improve the benefit of clozapine and/or limit some of the unwanted effects of clozapine, compared to not adding fish oil. Fish oil is a medication used to reduce levels of some fats (triglycerides) in blood. Some studies have found that adding fish oil reduces psychosis (voices, suspiciousness). However the FDA has not approved fish oil for reducing psychosis, so for this study the use of fish oil is investigational. This study will test whether fish oil can help people with schizophrenia or schizoaffective disorders have less psychosis. Fish oil is not an antipsychotic medication.

Conditions

Interventions

DRUG

Metformin

DRUG

Fish Oil

Sponsors & Collaborators

Principal Investigators

  • Joseph McEvoy, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-02-28
Completion
2013-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02140788 on ClinicalTrials.gov