Note: This study is currently only recruiting patients in the hospital.

If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.

A Pilot Study Investigating the Efficacy of Minocycline and N-acetylcysteine for Bipolar Depression

This particular study involves adding an FDA approved antibiotic, minocycline, and/or an FDA approved mucolytic, n-acetylcysteine, to mood stabilizing treatment for bipolar depression.

Massachusetts General Hospital Bipolar Disorder Medicines
5 visits over 8 weeks
Estimated Time Commitment
Any Sex/Gender, 18-65 years
May Be Eligible
Payment up to $300
May Be Offered
Blood draw, Survey, Medication, Office visit
May Be Required
 
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This project is not recruiting.

Overview

What we are studying

This particular study involves adding an FDA approved antibiotic, minocycline, and/or an FDA approved mucolytic, n-acetylcysteine, to mood stabilizing treatment for bipolar depression. The goal of the study is to test the effectiveness of widely available and inexpensive medications to treat this condition. We want to know if this medication, when added to treatment as usual, will improve depressive symptoms and quality of life.


Why it is important


What we hope to accomplish

Principal Investigator

Andrew Nierenberg, MD

Massachusetts General Hospital

Public Profile

Who can participate


  • Diagnosis of Bipolar Disorder

  • Age > 18 years and < 65 years

  • Currently depressed

  • Participants will remain on an FDA approved anti-manic drug during the study

What you may be asked to do

It will take you 8 weeks to complete this research study. During this time, we will ask you to attend 5 study visits to MGH.


First, we would like you to come for a 1-3 hour long screening visit at a clinical office in the BCRP. You will be asked to complete a few questionnaires to determine whether you qualify for the study, we will check vital signs, perform an ECG if necessary, draw a blood sample, and test your urine for pregnancy (females).


If you qualify for the study, we will ask you to return for a baseline visit at the BCRP. This second session will take 1-2 hours. If you still qualify for the study, we will assign you by chance (like a coin toss) to the minocycline group, the N-acetylcysteine group, the minocycline and NAC group, or the placebo group. You and the study doctor cannot choose your study group. You will have a 1 in 4 chance of being assigned to each group. You and the study doctor will not know which study group you are in, but s/he can find out if necessary. During the baseline visit, we will ask you to complete mood rating scales with the study psychiatrist and complete questionnaires, and check your vital signs.


At visits 3 and 4, we will also ask you to complete mood rating scales with the study psychiatrist and complete questionnaires, and check your vital signs.


At visit 5, we will ask you to complete mood rating scales with the study psychiatrist and complete questionnaires, check your vitals, and draw a blood sample. 


Project activities may include:

  • Blood draw
  • Survey
  • Medication
  • Office visit

Estimated Time Commitment

5 visits over 8 weeks

What You May Get

Participants will be paid $300 for completion of the study. If they do not complete the study, they will be paid $50 for each visit they complete.

Location

MGH Bipolar Clinic and Research Program
50 Staniford Street, Suite 580 Boston, MA 02114

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Travel

  • Accessible by public transportation
  • Parking available

Travel and Parking Details

Additional Information

ClinicalTrials.gov Identifier

NCT02719392


Study Phase

Phase 4: This project studies a drug or treatment that has already been approved by the FDA and studied in both healthy volunteers and participants with specific diseases or conditions. It will gather more information about long term safety and will help to understand how the drug or treatment can be most effective.


Participating Institutions


Funding Source

  • Department
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