A Phase 4 interventional study of Metformin and Fish Oil in Schizophrenia and Schizo-affective Disorder, sponsored by Duke University. Terminated. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-10-26.
Sponsored by Duke University · Phase 4, Interventional, and Other
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.
3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.
This study's enrollment of 34 is below the median of 70 across 2,924 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Duke University is the lead sponsor of 2,058 studies on the registry; 274 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 165 (81%) have results posted.
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Exclusion Criteria:
patients who have contraindications to metformin use, such as:
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.
Drug: Metformin
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.
Drug: 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.
Drug: Metformin · Drug: Fish Oil
Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
Change in Weight
Time frame: baseline, 2 weeks, 4 weeks
Changes in Fasting Levels of Non-HDL Cholesterol and Triglycerides
Time frame: baseline, 2 weeks, 4 weeks
Changes in C-reactive Protein and Sedimentation Rates
Time frame: 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
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.
Time frame: baseline, 2 weeks, 4 weeks
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.
| Milestone | Metformin | Fish Oil | Metformin and Fish Oil | No Medication Added |
|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
The four positive items are: Suspiciousness, Unusual Thought Content, Hallucinations, Conceptual Disorganization.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Metformin | — | — | — |
| Fish Oil | — | — | — |
| Metformin and Fish Oil | — | — | — |
| No Medication Added | — | — | — |
Subjects who signed a consent form
| Age, Categorical(Participants) | All Subjects Who Consented |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 34 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | All Subjects Who Consented |
|---|---|
| Female | 13 |
| Male | 21 |
| Region of Enrollment(participants) | All Subjects Who Consented |
|---|---|
| United States | 34 |
No study locations are listed for this record.
The record gives a start of May 2011, a primary completion of Feb 2013 and a completion of Feb 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2014, 1 year 9 months after primary completion.
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This study is terminated, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Metformin · Fish Oils