SchizophreniaPhase 4NCT02140788
Effects of Metformin and Fish Oil on Treatment With Clozapine
A Phase 4 study testing Metformin and Fish Oil in people with Schizophrenia and Schizo-affective Disorder, run by Duke University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Schizo-affective Disorder
- What is being tested?
- Metformin and Fish Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Feb 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
About this study
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
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
- Being tested
- Metformin, Fish Oil
- Keywords
- schizophrenia, schizo-affective disorder
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Fish OilDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Metformin |
| 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. Receives: Drug: Fish Oil |
| 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. Receives: Drug: Metformin; Drug: Fish Oil |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Measured: baseline, 2 weeks, 4 weeks
Secondary outcomes (4)
Changes in Fasting Levels of Non-HDL Cholesterol and Triglycerides
Measured: baseline, 2 weeks, 4 weeks
Changes in C-reactive Protein and Sedimentation Rates
Measured: baseline, 2 weeks, 4 weeks
Changes in Mole Percentages of Omega-3 PUFAs in Fasting Serum and RBC Membranes
Measured: 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.
Measured: baseline, 2 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startMay 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph McEvoy, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140788
- Sponsor's protocol ID
- Pro00027822
- Status last verified
- May 2014
- First submitted
- 14 May 2014
- Last updated
- 26 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02140788
- Acronym / sponsor ID
- Pro00027822
- Conditions
- Schizophrenia, Schizo-affective Disorder
- Keywords
- schizophrenia, schizo-affective disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 16 May 2014 (estimated)
- Results
- Posted 14 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: MetforminSubjects 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 | Drug: Fish OilSubjects 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 | Drug: Metformin, Drug: Fish OilSubjects 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin | Drug | Metformin, Metformin and Fish Oil |
| Fish Oil | Drug | Fish Oil, Metformin and Fish Oil |
Primary outcome
Change in Weight
Time frame: baseline, 2 weeks, 4 weeks
4 secondary outcomes
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
Time frame: baseline, 2 weeks, 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph McEvoy, MD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin and Fish Oil in people with Schizophrenia and Schizo-affective Disorder, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weight (time frame: baseline, 2 weeks, 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.