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Minocycline for Bipolar Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01514422
First Posted: January 23, 2012
Last Update Posted: January 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dan V. Iosifescu, Icahn School of Medicine at Mount Sinai
Results First Submitted: September 29, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Bipolar Depression
Intervention: Drug: Minocycline

  Participant Flow
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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
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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
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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
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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
First Submitted: January 10, 2012
First Posted: January 23, 2012
Results First Submitted: September 29, 2016
Results First Posted: January 30, 2017
Last Update Posted: January 30, 2017