Obesity, Schizophrenia
Conditions
Keywords
schizophrenia, antipsychotics, obesity, diabetes
Brief summary
Study hypothesis is that patients on antipsychotics medication treated with metformin will show loss in weight and improved measures of glucose metabolism.
Detailed description
Patients who had gained more than 10 lbs of weight in the last 3 months or had BMI of 35 or greater were treated with metformin up to 2500 mg/day in an open label study of up to 3 months time. Changes in weight and glucose measures were recorded.
Interventions
DRUGMetformin
metformin 500- 2500 mg/day. Patient received variable doses of metformin starting at 500 mg/day and increasing up to maximum of 2500 mg/day over 3-4 weeks. Dose was titrated on tolerability and side effects, especially development of hypoglycemia. This explains why different patients received different maximum doses.
Sponsors
Nathan Kline Institute for Psychiatric Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients will be 18-70 years of age; * Currently hospitalized or an outpatient at MPC; * BMI ≥ 35 or excessive recent weight gain ( \> than 10 lb weight gain in the past 3 months); * Patients will have a diagnosis of schizophrenia or schizoaffective disorder or bipolar disorder.
Exclusion criteria
* Age below 18 or over 70; * Patient is currently already treated with metformin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight (wt) in Pounds (Lbs).. | baseline, 4 weeks, 8 weeks, 12 weeks | Patients weight in pounds |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Levels | baseline, 4 weeks, 8 weeks, 12 weeks | Fasting glucose |
| Insulin Level | baseline, 4 weks, 8 weeks, 12 weeks | fasting serum insulin uIU/ml. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Metformin Metformin: metformin 500- 2500 mg/day. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Metformin |
|---|---|
| Age, Continuous | 38.5 years STANDARD_DEVIATION 10.2 |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 2 / 12 |
Outcome results
Primary
Weight (wt) in Pounds (Lbs)..
Patients weight in pounds
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metformin | Weight (wt) in Pounds (Lbs).. | baseline wt lbs | 250.97 weight(wt) in pounds(lbs) | Standard Error 11.52 |
| Metformin | Weight (wt) in Pounds (Lbs).. | 4 week wt lbs | 244.73 weight(wt) in pounds(lbs) | Standard Error 10.84 |
| Metformin | Weight (wt) in Pounds (Lbs).. | 8 week wt lbs | 244.15 weight(wt) in pounds(lbs) | Standard Error 10.06 |
| Metformin | Weight (wt) in Pounds (Lbs).. | 12 week wt lbs | 240.44 weight(wt) in pounds(lbs) | Standard Error 9.22 |
Secondary
Glucose Levels
Fasting glucose
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metformin | Glucose Levels | basline glucose | 111.05 mg/dL | Standard Error 12.83 |
| Metformin | Glucose Levels | week 4 glucose | 87.00 mg/dL | Standard Error 2.95 |
| Metformin | Glucose Levels | week 8 glucose | 89.17 mg/dL | Standard Error 2.17 |
| Metformin | Glucose Levels | week 12 gluocse | 94.25 mg/dL | Standard Error 3.85 |
Secondary
Insulin Level
fasting serum insulin uIU/ml.
Time frame: baseline, 4 weks, 8 weeks, 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metformin | Insulin Level | week 12 insulin | 11.29 uIU/ml | Standard Error 2.39 |
| Metformin | Insulin Level | baseline insulin | 11.18 uIU/ml | Standard Error 1.32 |
| Metformin | Insulin Level | week 4 insulin | 11.53 uIU/ml | Standard Error 21.71 |
| Metformin | Insulin Level | week 8 insulin | 8.85 uIU/ml | Standard Error 1.41 |