Minocycline for Bipolar Depression

Completed · Phase 4

Conditions studied: Bipolar Depression

In brief

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.

Key facts

Study ID

NCT01514422

Run by

Icahn School of Medicine at Mount Sinai

People needed

20

Starts

2011-05-01

Expected to finish

2013-08-01

Last updated by the study team

2017-01-30

Who can join

Age: 18 and older, up to 68. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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