A Phase 4 interventional study of Metformin and Placebo in Diabetes Mellitus, Type 2 and Schizophrenia, sponsored by Centre for Addiction and Mental Health. Completed at 1 site in Canada. Open to participants aged 17 Years to 45 Years. Per ClinicalTrials.gov, last updated 2018-07-30.
Sponsored by Centre for Addiction and Mental Health · Phase 4, Interventional, and Treatment
Schizophrenia is associated with a lifespan shortened by 20 years, due to cardiovascular disease (CVD), with antipsychotic (AP) medications understood to contribute to this risk through associated metabolic side-effects. Metformin, a medication used to treat prediabetes, and diabetes in the general population, holds promise with regard to reduction of AP-related metabolic problems, but has not been directly tested in early episode patients beyond weight loss, nor specifically in patients with diabetes or prediabetes and psychosis. We propose to replicate findings that metformin can reduce weight gain, and dysglycemia uniquely focusing on an early episode population diagnosed with prediabetes or diabetes. To help determine long-term risk/benefit of adjunctive metformin, we propose to look at changes in abdominal and liver fat, two well-established risk factors for CVD. Given links between dysglycemia, obesity with hippocampal volume loss and cognitive dysfunction, we will explore if improvements in metabolic indices are associated in changes in cognition and brain structure.
This is a 16 week, double-blind, randomized pilot study, which proposes to recruit 24 patients with schizophrenia, or schizoaffective disorders (DSM 5), who are overweight or obese (BMI >25) and have prediabetes or type 2 diabetes. Randomization occurs on a 2:1 basis, with 16 patients randomised to metformin, and 8 to placebo. Metfomin/placebo is dispensed monthly. The baseline and /or screening visit includes a physical exam (including anthropometric measures), medical history, fasting blood work (glucose, insulin, HbA1c, lipids, electrolytes, thyroid, liver/kidney function), in addition to a urine drug screen. Women of child-bearing age are given a pregnancy test. Patients who meet inclusion criteria and consent to the study have an oral glucose tolerance test (OGTT), and a baseline abdominal and brain MRI (to respectively assess visceral adiposity, a key risk factor for CV disease, and hippocampal volumes). Anthropometric measures and pill counts are repeated bi-weekly. At week 8, fasting insulin/glucose, HbA1C, and liver function tests are measured. End of study measures (week 16), include the same panel of bloodwork conducted at baseline, as well as a repeat OGTT, and an abdominal and brain MRI. Rountine psychopathology scales, including BPRS, CGI, and CDS will be measured at baseline, and week 16. The Brief Assessment of Cognition in Schizophrenia (BACS) will also be completed at baseline, and study end.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 35 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Centre for Addiction and Mental Health is the lead sponsor of 327 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
Metformin/ placebo will be dispensed on a biweekly basis, and pill counts conducted at each visit.
Drug: Metformin
Metformin/ placebo will be dispensed on a biweekly basis, and pill counts conducted at each visit.
Drug: Placebo
Metformin will be dispensed on a biweekly basis, and pill counts conducted at each visit.
Placebo will be dispensed on a biweekly basis, and pill counts conducted at each visit.
Also known as: Sugar pill
Improvement in HbA1C derived from Oral glucose tolerance test (Matsuda, index of insulin sensitivity; area under glucose curve; insulin secretion sensitivity index-2 (ISSI-2))
HbA1c value assessment
Time frame: 3 years
Decreases in visceral adiposity
Visceral adiposity assessment via MRI
Time frame: 3 years
Decreases in hepatic adiposity
Hepatic adiposity assessment via MRI
Time frame: 3 years
Greater than 5% decrease in body weight
Body weight assessment
Time frame: 3 years
Improvements in cognition
Cognition assessment
Time frame: 3 years
Improvements in hippocampal volume
Cognition assessment
Time frame: 3 years
Plan to share: No
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Centre for Addiction and Mental Health