Status:
COMPLETED
Minocycline for Bipolar Depression
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Bipolar Depression
Eligibility:
All Genders
18-68 years
Phase:
PHASE4
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 ...
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 olan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01514422
Start Date
May 1 2011
End Date
August 1 2013
Last Update
January 30 2017
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029