Evaluating the Efficacy of Adjunctive Minocycline for the Treatment of Bipolar Depression
NCT01403662 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2016-12-19
Summary
Long-term studies have emphasized that depressive symptoms and episodes account for majority of the illness burden experienced by individuals with bipolar disorder (BD). Previous studies have shown that blood levels of proteins called pro-inflammatory cytokines are abnormal in individuals with bipolar depression. The investigators hypothesize that preventing the production or release of pro-inflammatory cytokines will result in improvement of depressive symptoms in individuals with bipolar depression. Minocycline is a medication that inhibits the activation of immune cells (i.e. microglia) in the brain and reduces the production of pro-inflammatory cytokines. Treatment with minocycline has been shown to have antidepressant-like effects in animal studies and improve symptoms of individuals with schizophrenia. In this study, minocycline (100 mg twice a day) will be administered for 8 weeks to determine if it is an efficacious antidepressant for individuals with bipolar depression.
Conditions
- Bipolar Disorder
- Bipolar Depression
- Bipolar I Depression
- Bipolar II Depression
Interventions
- DRUG
-
Minocycline
Minocycline (100 mg bid) will be administered as an adjunctive agent to conventional Health Canada-approved, or first-line CANMAT bipolar guideline-recommended, agents for bipolar disorder.
Sponsors & Collaborators
-
University Health Network, Toronto
lead OTHER
Principal Investigators
-
Roger S McIntyre, MD, FRCPC · University Health Network, Toronto
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-07-31
- Primary Completion
- 2014-02-28
- Completion
- 2014-12-31
Countries
- Canada
Study Locations
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