- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Metformin
Subjects will continue to take the clozapine prescribed as standard of care.
Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper.
Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.
|
|
Active Comparator: Fish Oil
Subjects will continue to take the clozapine prescribed as standard of care.
Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper.
Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.
|
|
Active Comparator: Metformin and Fish Oil
Subjects will continue to take the clozapine prescribed as standard of care.
Subjects will receive Metformin and Fish Oil as part of the study.
|
|
No Intervention: No medication added
Subjects will continue to take the clozapine prescribed as standard of care.
Subjects will not receive Metformin or Fish Oil.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Weight
Time Frame: baseline, 2 weeks, 4 weeks
|
baseline, 2 weeks, 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Fasting Levels of Non-HDL Cholesterol and Triglycerides
Time Frame: baseline, 2 weeks, 4 weeks
|
baseline, 2 weeks, 4 weeks
|
|
Changes in C-reactive Protein and Sedimentation Rates
Time Frame: baseline, 2 weeks, 4 weeks
|
baseline, 2 weeks, 4 weeks
|
|
Changes in Mole Percentages of Omega-3 PUFAs in Fasting Serum and RBC Membranes
Time Frame: baseline, 2 weeks, 4 weeks
|
baseline, 2 weeks, 4 weeks
|
|
Changes in Total Scores on the 4 Positive Brief Psychiatric Rating Scale (BPRS) Items
Time Frame: baseline, 2 weeks, 4 weeks
|
The four positive items are: Suspiciousness, Unusual Thought Content, Hallucinations, Conceptual Disorganization.
|
baseline, 2 weeks, 4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joseph McEvoy, MD, Duke University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00027822
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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