Clinical Trials Directory

Trials / Completed

CompletedNCT01514422

Minocycline for Bipolar Depression

Minocycline for Bipolar Disorder

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Icahn School of Medicine at Mount Sinai · Academic / Other
Sex
All
Age
18 Years – 68 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to evaluate minocycline as a potential treatment for bipolar depression when added to a mood-stabilizing medication. Minocycline is an antibiotic that is approved for the treatment of infections and acne. Participation in this research study is expected to last 8 weeks, and includes five outpatient visits.

Detailed description

Bipolar depression remains the great unmet need in the treatment of bipolar disorder. Only two treatments have been FDA-approved for the management of acute bipolar depression (the combination of olanzapine and fluoxetine and quetiapine). Early pilot data suggests the drug minocycline has potent antidepressant effects. Minocycline is approved by the Food and Drug Administration (FDA) (for acne and bacterial infections), is inexpensive and readily available in generic formulation, and is generally well-tolerated. This study will examine whether administering the drug minocycline to individuals with bipolar depression over 8 weeks will improve their depressive symptoms. This study will also offer an option to participate in proton magnetic resonance spectroscopy (1H-MRS) to measure N-Acetylaspartate (NAA) levels in the brain, which are thought to be decreased in bipolar disorder.

Conditions

Interventions

TypeNameDescription
DRUGMinocyclineMinocycline 100 to 300mg per day for 8 weeks

Timeline

Start date
2011-05-01
Primary completion
2013-08-01
Completion
2013-08-01
First posted
2012-01-23
Last updated
2017-01-30
Results posted
2017-01-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01514422. Inclusion in this directory is not an endorsement.