Minocycline for Bipolar Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dan V. Iosifescu, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01514422
First received: January 10, 2012
Last updated: March 12, 2014
Last verified: March 2014

January 10, 2012
March 12, 2014
May 2011
August 2013   (final data collection date for primary outcome measure)
Change in scores on the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: baseline and week 8 ] [ Designated as safety issue: No ]
Measured at baseline and week 8
Same as current
Complete list of historical versions of study NCT01514422 on ClinicalTrials.gov Archive Site
  • Change in N-acetylaspartate (NAA), as measured by 1H-MRS scan [ Time Frame: baseline and week 8 ] [ Designated as safety issue: No ]
    Measured at baseline and week 8
  • Changes in Young Mania Rating Scale (YMRS) [ Time Frame: baseline and week 8 ] [ Designated as safety issue: Yes ]
    Measured at baseline and week 8
Same as current
Not Provided
Not Provided
 
Minocycline for Bipolar Depression
Minocycline for Bipolar Disorder

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.

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Bipolar Depression
Drug: Minocycline
Minocycline 100 to 300mg per day for 8 weeks
Other Name: Minocin
Experimental: Minocycline
All subjects will be given minocycline over 8 weeks
Intervention: Drug: Minocycline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 68 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01514422
GCO 11-0432
No
Dan V. Iosifescu, Mount Sinai School of Medicine
Mount Sinai School of Medicine
Not Provided
Principal Investigator: Dan V Iosifescu, MD, MSc Mount Sinai School of Medicine
Mount Sinai School of Medicine
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP