Bipolar Disorder | Evaluating the Efficacy of Adjunctive Minocycline for the Treatment of Bipolar Depression
Bipolar Disorder research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - Diagnosis of bipolar I or II disorder - Meets criteria for a current major depressive episode - A score of >= 20 on the HAMD-17 at the time of enrollment and at baseline - Episode duration will be greater than 4 weeks but not longer than 12 months. Exclusion Criteria: - Insufficiently responding to >2 treatment strategies FDA/Health Canada-approved/guideline recommended for bipolar depression - Acute manic or mixed episode - An Axis I psychiatric disorder requiring primary clinical attention - Clinically significant medical illness - Treatment with minocycline or β-lactam antibiotics in the preceding 6 months - Hypersensitivity to minocycline or any other tetracycline - Physical injury requiring medical treatment or surgery in the last 6 months - Pregnant or breast-feeding - Inability to provide written informed consent.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Bipolar I Depression
Bipolar II Depression
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:MinocyclineMinocycline (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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: July 2011
Completed Date: December 2014
Phase: Phase 3
Primary Outcome: Change from baseline to week 8 on the Montgomery Asberg Depression Rating Scale (MADRS)
Secondary Outcome: Change from baseline to week 8 on the Hamilton Depression Rating Scale 17-item (HAMD-17)
Study sponsors, principal investigator, and references
Principal Investigator: Roger S McIntyre, MD, FRCPC
Lead Sponsor: University Health Network, Toronto
Levkovitz Y, Mendlovich S, Riwkes S, Braw Y, Levkovitch-Verbin H, Gal G, Fennig S, Treves I, Kron S. A double-blind, randomized study of minocycline for the treatment of negative and cognitive symptoms in early-phase schizophrenia. J Clin Psychiatry. 2010 Feb;71(2):138-49. doi: 10.4088/JCP.08m04666yel. Epub 2009 Nov 3.