Minocycline for Bipolar Depression

Phase 4

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Meets DSM-IV criteria for Bipolar I Disorder or Bipolar II disorder, depressed phase
A baseline score of at least 18 on the Montgomery-Asberg Depression Rating Scale (MADRS)
Participants on mood stabilizer medication for at least two weeks prior to starting the study, and must remain on the treatment during the study
Able to understand English

Exclusion Criteria

DSM-IV diagnosis of Bipolar NOS, Cyclothymia, or Schizoaffective Bipolar type
Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, partner with vasectomy)
Serious suicide or homicide risk
Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
Clinical or laboratory evidence of hypothyroidism; if maintained on thyroid medication must be euthyroid for at least 1 month before visit 1
Drug/alcohol dependence within past 30 days, or current substance use disorder that requires detoxification
Current use of minocycline or history of anaphylactic reaction or intolerance to minocycline
Primary clinical diagnosis of antisocial or borderline personality disorder
Patients with metallic foreign bodies or claustrophobia will be excluded from the MRS component

Arm && Interventions

Group	Intervention	Description
Minocycline	Minocycline	All subjects will be given minocycline over 8 weeks

Primary Outcome Measures

Name	Time	Method
Change in Scores on the Montgomery-Asberg Depression Rating Scale (MADRS)	baseline and week 8	Measured at baseline and week 8. The MADRS-S has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).

Secondary Outcome Measures

Name	Time	Method
Change in N-acetylaspartate (NAA), as Measured by 1H-MRS Scan	baseline and week 8	Measured at baseline and week 8
Changes in Young Mania Rating Scale (YMRS)	baseline and week 8	Measured at baseline and week 8. The YMRS is an 11-item questionnaire to measure the severity of manic symptoms. 7 items are scored 0-4 and the other 4 items are scored 0-8, with overall score range from 0 (normal) to 60 (severe mania).