NCT02140788

Effects of Metformin and Fish Oil on Treatment With Clozapine

A Comparison Of The Effects Of Added Metformin (Versus No Added Metformin) On Psychopathology, Lipids, And Measures of Inflammation During The Initiation Or Re-Institution Of Treatment With Clozapine In Patients With Schizophrenia Or Schizoaffective Disorder

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

• Schizophrenia
• Schizo-affective Disorder

Interventions

Type	Name	Description
DRUG	Metformin
DRUG	Fish Oil

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2014-05-16
• Last updated: 2023-10-26
• Results posted: 2014-11-14