Evaluating the Efficacy of Adjunctive Minocycline for the Treatment of Bipolar Depression

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Minocycline

Criteria

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.