Treating Insulin Resistance as a Strategy to Improve Outcome in Refractory Bipolar Disorder
Completed · Phase 3 · Has a placebo group
Conditions studied: Bipolar Disorder
In brief
In a previous study by Dr. Calkin, the principal investigator of this study, persons with bipolar disorder and either type II diabetes or insulin resistance were found to experience more severe symptoms of bipolar illness and a lower response to treatment, compared to persons with bipolar disorder who did not have type II diabetes or insulin resistance. To further explore these findings, the investigators have developed this study to see if treating insulin resistance (using metformin, a drug used to improve the body's use of insulin) may also help improve the symptoms of bipolar illness.
Key facts
- Study ID
- NCT02519543
- Run by
- Cynthia Calkin
- People needed
- 50
- Starts
- 2015-09-01
- Expected to finish
- 2020-09-01
- Last updated by the study team
- 2021-01-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 years of age or older
- diagnosis of BD I or II
- non-remitting BD as defined by the presence of mood symptoms of at least moderate severity, indicated by a MADRS score ≥ 15 despite being on optimal treatment according to the CANMAT/APA guidelines
- HOMA-IR ≥ 1.8, indicating IR (subjects will have FPG and FSI testing done to determine whether they have IR or T2D)
- current episode of depression 4 weeks or longer in duration
- on a stable optimal dose of mood stabilizing treatment for at least 4 weeks prior to study entry
You may not qualify if…
- Diagnoses of organic mood disorder, mood disorder not otherwise specified, alcohol dependence, T1D or T2D
- presence of rapid cycling (by DSM-5 criteria), mania, (indicated by a Young Mania Rating Scale [YMRS] score > 15), or suicide ideation (current score of 5 on the Suicidal Ideation section of the Columbia-Suicide Severity Rating scale [C-SSRS])
- patient receiving metformin < 2 weeks prior to study entry
- metformin allergy or sensitivity
- metformin contraindicated where liver function tests > three times the upper limit of normal, estimated glomerular filtration rate (eGFR) < 30, CBC revealing megaloblastic anemia or pre-existing untreated B12 deficiency
- pregnancy or breastfeeding
- lactose intolerance, diagnosed by a physician
- chronic use of narcotic medications
- patient lacks full capacity to consent to study participation.
Where it is running
- Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, University of Pittsburgh — Pittsburgh, Pennsylvania, United States
- Nova Scotia Health Authority - Dept. of Psychiatry — Halifax, Nova Scotia, Canada
Full record on ClinicalTrials.gov
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