This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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
Results First Received: September 29, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Bipolar Depression
Intervention: Drug: Minocycline

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study procedures were conducted between June 2011 and June 2013 at the Mood and Anxiety Disorders Program at Icahn School of Medicine at Mount Sinai.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Minocycline Minocycline 100 to 300mg per day for 8 weeks

Participant Flow:   Overall Study
    Minocycline
STARTED   20 
COMPLETED   19 
NOT COMPLETED   1 
Lost to Follow-up                1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Minocycline Minocycline 100 to 300mg per day for 8 weeks

Baseline Measures
   Minocycline 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.6  (12.7) 
Gender 
[Units: Participants]
Count of Participants
 
Female      8  40.0% 
Male      12  60.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Scores on the Montgomery-Asberg Depression Rating Scale (MADRS)   [ Time Frame: baseline and week 8 ]

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

3.  Secondary:   Changes in Young Mania Rating Scale (YMRS)   [ Time Frame: baseline and week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitations are this is an open label study with no placebo and low number of subjects.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Dan V. Iosifescu
Organization: Mood and Anxiety Disorders Program, Icahn School of Medicine at Mount Sinai
phone: 212-241-4480
e-mail: dan.iosifescu@mssm.edu



Responsible Party: Dan V. Iosifescu, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01514422     History of Changes
Other Study ID Numbers: GCO 11-0432
Study First Received: January 10, 2012
Results First Received: September 29, 2016
Last Updated: December 6, 2016