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PI left institution
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Active Comparator | 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. |
|
| Fish Oil | Active Comparator | 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. |
|
| Metformin and Fish Oil | Active Comparator | 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 medication added | No Intervention | Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug |
| ||
| Fish Oil |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight | baseline, 2 weeks, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Fasting Levels of Non-HDL Cholesterol and Triglycerides | baseline, 2 weeks, 4 weeks | |
| Changes in C-reactive Protein and Sedimentation Rates | baseline, 2 weeks, 4 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
patients who have contraindications to metformin use, such as:
patients with blood dyscrasias that could be worsened by added fish oil
women who are pregnant or breastfeeding
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| Name | Affiliation | Role |
|---|---|---|
| Joseph McEvoy, MD | Duke University | Principal Investigator |
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Thirty-four subjects were consented to the study; however, were never randomized. The study was terminated in Feb 2013 and no data was collected or analyzed.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Metformin |
| FG001 | 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. Fish Oil |
| FG002 | 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. Metformin Fish Oil |
| FG003 | No Medication Added | Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects who signed a consent form
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects Who Consented | All subjects who signed a consent form |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Weight | Patients were not randomized per protocol and the study was terminated. Data analysis was not performed. | Posted | baseline, 2 weeks, 4 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Metformin |
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Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph P. McEvoy | Duke University Health System | 919-819-9295 | JMCEVOY@gru.edu |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D009821 |
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|
| Changes in Mole Percentages of Omega-3 PUFAs in Fasting Serum and RBC Membranes |
| baseline, 2 weeks, 4 weeks |
| Changes in Total Scores on the 4 Positive Brief Psychiatric Rating Scale (BPRS) Items | The four positive items are: Suspiciousness, Unusual Thought Content, Hallucinations, Conceptual Disorganization. | baseline, 2 weeks, 4 weeks |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 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. Metformin Fish Oil |
| OG003 | No Medication Added | Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil. |
|
| Secondary | Changes in Fasting Levels of Non-HDL Cholesterol and Triglycerides | Patients were not randomized per protocol and the study was terminated. Data analysis was not performed. | Posted | baseline, 2 weeks, 4 weeks |
|
|
| Secondary | Changes in C-reactive Protein and Sedimentation Rates | Patients were not randomized per protocol and the study was terminated. Data analysis was not performed. | Posted | baseline, 2 weeks, 4 weeks |
|
|
| Secondary | Changes in Mole Percentages of Omega-3 PUFAs in Fasting Serum and RBC Membranes | Patients were not randomized per protocol and the study was terminated. Data analysis was not performed. | Posted | baseline, 2 weeks, 4 weeks |
|
|
| Secondary | Changes in Total Scores on the 4 Positive Brief Psychiatric Rating Scale (BPRS) Items | The four positive items are: Suspiciousness, Unusual Thought Content, Hallucinations, Conceptual Disorganization. | Patients were not randomized per protocol and the study was terminated. Data analysis was not performed. | Posted | baseline, 2 weeks, 4 weeks |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. Fish Oil | 0 | 0 | 0 | 0 |
| EG002 | 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. Metformin Fish Oil | 0 | 0 | 0 | 0 |
| EG003 | No Medication Added | Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil. | 0 | 0 | 0 | 0 |
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| Oils |
| D008055 | Lipids |