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
  Purpose

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.


Condition Intervention Phase
Bipolar Depression
Drug: Minocycline
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Minocycline for Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 39
Study Start Date: May 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Minocycline
All subjects will be given minocycline over 8 weeks
Drug: Minocycline
Minocycline 100 to 300mg per day for 8 weeks
Other Name: Minocin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514422

Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Dan V Iosifescu, MD, MSc Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Dan V. Iosifescu, Associate Professor, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01514422     History of Changes
Other Study ID Numbers: GCO 11-0432
Study First Received: January 10, 2012
Last Updated: March 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Bipolar disorder
depression
minocycline
mood disorders
bipolar depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Affective Disorders, Psychotic
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014