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
| Type | Name | Description |
|---|---|---|
| DRUG | Minocycline | Minocycline 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.