NCT01514422

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 23, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

January 30, 2017

Completed
Last Updated

January 30, 2017

Status Verified

December 1, 2016

Enrollment Period

2.3 years

First QC Date

January 10, 2012

Results QC Date

September 29, 2016

Last Update Submit

December 6, 2016

Conditions

Bipolar Depression

Keywords

Bipolar disorderdepressionminocyclinemood disordersbipolar depression

Outcome Measures

Primary Outcomes (1)

  • 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).

    baseline and week 8

Secondary Outcomes (2)

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

    baseline and week 8

  • Changes in Young Mania Rating Scale (YMRS)

    baseline and week 8

Study Arms (1)

Minocycline

EXPERIMENTAL

All subjects will be given minocycline over 8 weeks

Drug: Minocycline

Interventions

MinocyclineDRUG

Minocycline 100 to 300mg per day for 8 weeks

Also known as: Minocin
Minocycline

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Bipolar DisorderDepressioncyclopia sequenceMood Disorders

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Limitations and Caveats

Limitations are this is an open label study with no placebo and low number of subjects.

Results Point of Contact

Title
Dr. Dan V. Iosifescu
Organization
Mood and Anxiety Disorders Program, Icahn School of Medicine at Mount Sinai
dan.iosifescu@mssm.edu
212-241-4480

Study Officials

  • Dan V Iosifescu, MD, MSc

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 10, 2012

First Posted

January 23, 2012

Study Start

May 1, 2011

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

January 30, 2017

Results First Posted

January 30, 2017

Record last verified: 2016-12

Locations

US(1)