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Note: This project posting has been updated.

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.

Try Bezafibrate - a new treatment drug for Bipolar Depression

This is a new medication study that looks into whether Bezafibrate can be used as an effective drug treatment for bipolar depression.

6 visits over 10 weeks
Estimated Time Commitment
Male, Female, 18-65 years
May Be Eligible
Payment up to $400
May Be Offered
Survey, Blood draw, Medication, Office visit, MRI scan, Biopsy
May Be Required
 
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Enrollment for this study is expected to close on Saturday, January 25, 2025

What we are studying

We are studying the effectiveness of Bezafibrate, a drug that lowers fat, in treating bipolar depression. 


Why it is important

Bipolar disorder is among the top causes of disability worldwide and negative health outcomes remain highly prevalent. Only 20% to 30% of bipolar patients achieve remission from a mood episode and even then, remain stable for two years. New drug development for bipolar disorder, and especially bipolar depression, has generally stalled in the past decade, with few new methods of treatment and no treatments developed specifically for bipolar disorder. Investigating whether Bezafibrate can be an effective drug treatment for bipolar depression can help improve patient outcomes.


What we hope to accomplish

We hope to determine the effectiveness of the novel drug treatment, Bezafibrate, in treating bipolar depression and expanding treatment options for Bipolar Disorder.

Principal Investigator

Andrew A Nierenberg, MD

Massachusetts General Hospital

Public Profile

Project Contact

Click I Am Interested "I Am Interested" "I Am Interested" to get started. If you have questions, contact:

Broghan O'Hearn
Clinical Research Coordinator

bohearn@mgh.harvard.edu
(617) 726-0360


  • Men or women between the ages of 18 and 65

  • Have a diagnosis of either Bipolar Disorder I or II

  • Currently taking a mood stabilizer 



  • Diagnosed with Bipolar Disorder ot otherwise specified (NOS), Schizoaffective Disorder, Substance Use disorders in the past 3 months, Schizophrenia, delusional disorders or psychotic disorders, Borderline or antisocial personality disorder, or OCD-spectrum disorders



  • Pregnant women

  • Individuals with unstable medical conditions (e.g., epilepsy, untreated endocrine disease, unstable angina, ulcers, impaired kidney functions)

  • Current use of or a known allergy to a fibrate

  • Current usage of MAOIs, statins, or anticoagulants

  • Individuals with Type 1 or 2 diabetes


  • Take study medication

  • Give blood to measure safety and treatment effect

  • Participate in 2, minimally invasive fat biopsies performed by a licensed expert with more than 15 years of experience in the procedure.

  • Participate in 2 brain scans using an MRI


 


Project activities may include:

  • Survey
  • Blood draw
  • Medication
  • Office visit
  • MRI scan
  • Biopsy

Estimated Time Commitment

6 visits over 10 weeks


All subjects will be provided with parking reimbursement and receive 8 weeks of medication treatment at no cost. If attending each study visit as scheduled, participants will be paid $300 at the end of the study. Participants involved in the MRI component of the study will also receive $50 for each scan, up to $100 total.


Travel

  • Parking reimbursed

Travel and Parking Details


ClinicalTrials.gov Identifier

NCT02481245


Study Phase

Phase 1: This project studies the safety of a medication or treatment, usually on healthy volunteers. It examines the medication or treatment’s effects on the body and looks for side effects.


Participating Institutions


Funding Source

  • Foundation
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