Schizo-affective Disorder, Schizophrenia
Conditions
Keywords
schizophrenia, schizo-affective disorder
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.
Interventions
DRUGMetformin
DRUGFish Oil
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Weight | baseline, 2 weeks, 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | baseline, 2 weeks, 4 weeks | The four positive items are: Suspiciousness, Unusual Thought Content, Hallucinations, Conceptual Disorganization. |
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects Who Consented All subjects who signed a consent form | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | All Subjects Who Consented |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants |
| Region of Enrollment United States | 34 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change in Weight
Time frame: baseline, 2 weeks, 4 weeks
Population: Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.
Secondary
Changes in C-reactive Protein and Sedimentation Rates
Time frame: baseline, 2 weeks, 4 weeks
Population: Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.
Secondary
Changes in Fasting Levels of Non-HDL Cholesterol and Triglycerides
Time frame: baseline, 2 weeks, 4 weeks
Population: Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.
Secondary
Changes in Mole Percentages of Omega-3 PUFAs in Fasting Serum and RBC Membranes
Time frame: baseline, 2 weeks, 4 weeks
Population: Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.
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.
Time frame: baseline, 2 weeks, 4 weeks
Population: Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.