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Minocycline for Bipolar Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dan V. Iosifescu, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT01514422
First received: January 10, 2012
Last updated: December 6, 2016
Last verified: December 2016

January 10, 2012
December 6, 2016
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 ]
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).
Change in Scores on the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: baseline and week 8 ]
Measured at baseline and week 8
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 ]
    Measured at baseline and week 8
  • Changes in Young Mania Rating Scale (YMRS) [ Time Frame: 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).
  • Change in N-acetylaspartate (NAA), as Measured by 1H-MRS Scan [ Time Frame: baseline and week 8 ]
    Measured at baseline and week 8
  • Changes in Young Mania Rating Scale (YMRS) [ Time Frame: baseline and week 8 ]
    Measured at baseline and week 8
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
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
20
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
Sexes Eligible for Study: All
18 Years to 68 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01514422
GCO 11-0432
No
Not Provided
Not Provided
Not Provided
Dan V. Iosifescu, Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
Not Provided
Principal Investigator: Dan V Iosifescu, MD, MSc Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
December 2016

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