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Minocycline for Bipolar Depression

Primary Purpose

Bipolar Depression

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Minocycline

About this trial

This is an interventional treatment trial for Bipolar Depression focused on measuring Bipolar disorder, depression, minocycline, mood disorders, bipolar depression

Eligibility Criteria

18 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Minocycline

Arm Description

All subjects will be given minocycline over 8 weeks

Outcomes

Primary Outcome Measures

Change in Scores on the Montgomery-Asberg Depression Rating Scale (MADRS)

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

Change in N-acetylaspartate (NAA), as Measured by 1H-MRS Scan

Measured at baseline and week 8

Changes in Young Mania Rating Scale (YMRS)

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).

Full Information

NCT ID

NCT01514422

First Posted

January 10, 2012

Last Updated

December 6, 2016

Sponsor

Icahn School of Medicine at Mount Sinai

1. Study Identification

Unique Protocol Identification Number

NCT01514422

Brief Title

Minocycline for Bipolar Depression

Official Title

Minocycline for Bipolar Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Icahn School of Medicine at Mount Sinai

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Depression

Keywords

Bipolar disorder, depression, minocycline, mood disorders, bipolar depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Minocycline

Arm Type

Experimental

Arm Description

All subjects will be given minocycline over 8 weeks

Intervention Type

Drug

Intervention Name(s)

Minocycline

Other Intervention Name(s)

Minocin

Intervention Description

Minocycline 100 to 300mg per day for 8 weeks

Primary Outcome Measure Information:

Title

Change in Scores on the Montgomery-Asberg Depression Rating Scale (MADRS)

Description

Time Frame

baseline and week 8

Secondary Outcome Measure Information:

Title

Change in N-acetylaspartate (NAA), as Measured by 1H-MRS Scan

Description

Measured at baseline and week 8

Time Frame

baseline and week 8

Title

Changes in Young Mania Rating Scale (YMRS)

Description

Time Frame

baseline and week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

68 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dan V Iosifescu, MD, MSc

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Icahn School of Medicine at Mount Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

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Minocycline for Bipolar Depression

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