Minocycline for Bipolar Depression

• ClinicalTrials.gov Identifier: NCT01514422
• Recruitment Status: Completed
• First Posted: January 23, 2012
• Results First Posted: January 30, 2017
• Last Update Posted: January 30, 2017
• Sponsor: Icahn School of Medicine at Mount Sinai
• Information provided by (Responsible Party): Dan V. Iosifescu, Icahn School of Medicine at Mount Sinai

Study Description

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 treatment of infections and acne. Participation in this research study is expected to last 8 weeks, and includes five outpatient visits.

Condition or disease	Intervention/treatment	Phase
Bipolar Depression	Drug: Minocycline	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Minocycline for Bipolar Disorder
• Study Start Date: May 2011
• Actual Primary Completion Date: August 2013
• Actual Study Completion Date: August 2013

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. Change in N-acetylaspartate (NAA), as Measured by 1H-MRS Scan [ Time Frame: baseline and week 8 ]
   Measured at baseline and week 8
2. 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 68 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, New York

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai

Investigators

• Principal Investigator: Dan V Iosifescu, MD, MSc; Icahn School of Medicine at Mount Sinai

More Information

• Responsible Party: Dan V. Iosifescu, Associate Professor, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT01514422
• Other Study ID Numbers: GCO 11-0432
• First Posted: January 23, 2012
• Results First Posted: January 30, 2017
• Last Update Posted: January 30, 2017
• Last Verified: December 2016

Keywords provided by Dan V. Iosifescu, Icahn School of Medicine at Mount Sinai:

Bipolar disorder; depression; minocycline; mood disorders; bipolar depression

Additional relevant MeSH terms:

Depression; Depressive Disorder; Bipolar Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders; Bipolar and Related Disorders; Minocycline; Anti-Bacterial Agents; Anti-Infective Agents