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

No results posted yet for this study

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

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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Entities

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 NCT01403662 on ClinicalTrials.gov