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PI moved to different institution. Decided to concentrate on different studies.
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Study hypothesis is that patients on antipsychotics medication treated with metformin will show loss in weight and improved measures of glucose metabolism.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight (wt) in Pounds (Lbs).. | Patients weight in pounds | baseline, 4 weeks, 8 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose Levels | Fasting glucose | baseline, 4 weeks, 8 weeks, 12 weeks |
| Insulin Level | fasting serum insulin uIU/ml. | baseline, 4 weks, 8 weeks, 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert C. Smith, MD PHD | Nathan Kline Institute for Psychiatric Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manhatan Psychiatric Center | New York | New York | 10035 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Metformin | Metformin: metformin 500- 2500 mg/day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metformin | Metformin: metformin 500- 2500 mg/day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Weight (wt) in Pounds (Lbs).. | Patients weight in pounds | Posted | Mean | Standard Error | weight(wt) in pounds(lbs) | baseline, 4 weeks, 8 weeks, 12 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 | Metformin: metformin 500- 2500 mg/day. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| low serum sodium, | Renal and urinary disorders | Non-systematic Assessment | patient developed low serum sodium while on additional medication chlorothiazide for kidney problems |
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This is an open non-blinded study in a small number of subjects. However, it is unlikely that outcomes measures of weight, glucose, and insulin, would have been likely to be affected by non-blinding of subjects and investigators. .
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert C smith MD | Nathan Kline insistute for Psychiatric Research | 845-298-6531 | rsmith@nki.rfmh.org |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D050177 | Overweight |
| D044343 | Overnutrition |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Glucose Levels | Fasting glucose | Posted | Mean | Standard Error | mg/dL | baseline, 4 weeks, 8 weeks, 12 weeks |
|
|
|
| Secondary | Insulin Level | fasting serum insulin uIU/ml. | Posted | Mean | Standard Error | uIU/ml | baseline, 4 weks, 8 weeks, 12 weeks |
|
|
|
| 2 |
| 12 |
| 0 |
| 12 |
|
| penumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | patient developed pneumonia after the study was completed; not related to study drug. |
|
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| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |