Effects of Metformin and Fish Oil on Treatment With Clozapine
Information source: Duke University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Schizo-affective Disorder
Intervention: Metformin (Drug); Fish Oil (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Duke University Official(s) and/or principal investigator(s): Joseph McEvoy, MD, Principal Investigator, Affiliation: Duke University
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label
Primary outcome: Change in Weight
Secondary outcome: Changes in Fasting Levels of Non-HDL Cholesterol and TriglyceridesChanges in C-reactive Protein and Sedimentation Rates Changes in Mole Percentages of Omega-3 PUFAs in Fasting Serum and RBC Membranes Changes in Total Scores on the 4 Positive Brief Psychiatric Rating Scale (BPRS) Items
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- male or female patients with clinical diagnoses of schizophrenia or schizo-affective
disorder
- between 18 and 60 years of age
- patients whose treating clinicians have recommended treatment with clozapine (and the
patients have agreed and provided signed informed consent for treatment with
clozapine)
Exclusion Criteria:
- patients who have contraindications to metformin use, such as:
- a diagnosis of congestive heart failure
- renal impairment (serum creatinine > 1. 5 in males; > 1. 4 in females)
- hepatic disease (AST or ALT > 2. 0 times upper limit of normal (ULN)
- positive hepatitis B surface antigen or hepatitis C antibody
- total bilirubin>1. 2x ULN; majority conjugated
- metabolic acidosis (serum CO2 < lower limit of normal),
- known hypersensitivity to metformin,
- recent (in the past 30 days) or scheduled radiological studies involving
iodinated contrast material
- alcohol abuse/dependence within the past month
- concurrent treatment with drugs that are known to increase metformin blood
levels including furosemide, nifedipine, and cationic drugs including
cimetidine, amiloride, digoxin, morphine, procainamide, quinidine, ranitidine,
triamterene, trimethoprim, and vancomycin
- patients with blood dyscrasias that could be worsened by added fish oil
- women who are pregnant or breastfeeding
Locations and Contacts
Additional Information
Starting date: May 2011
Last updated: November 6, 2014
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