Effects of Metformin and Fish Oil on Treatment With Clozapine

NCT ID: NCT02140788

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Fish Oil

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

Fish Oil

Intervention Type: DRUG

No medication added

Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Metformin

Intervention Type: DRUG

Fish Oil

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph McEvoy, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Other Identifiers

Pro00027822

Identifier Type: -

Identifier Source: org_study_id