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Treating Insulin Resistance as a Strategy to Improve Outcome in Refractory Bipolar Disorder

NCT02519543 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-01-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Placebo

Placebo to be given twice daily, once with breakfast and once with supper

DRUG

Metformin

Active experimental drug to be given twice a day, 1000 mg with breakfast and 1000 mg with supper

Sponsors & Collaborators

  • Stanley Medical Research Institute

    collaborator OTHER

  • Cynthia Calkin

    lead OTHER

Principal Investigators

  • Cynthia Calkin, MD FRCPC · Nova Scotia Health Authority

  • Roy Chengappa, MD FRCPC · Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02519543 on ClinicalTrials.gov