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Bezafibrate for Bipolar Disorder

Phase 2
Waitlist Available
Led By Andrew A. Nierenberg, M.D.
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 8
Awards & highlights

Study Summary

This trial will test the hypothesis that bezafibrate, a pan-PPAR agonist, may be effective and safe for bipolar depression. The trial will last 8 weeks and will include 30 participants.

Eligible Conditions
  • Bipolar Disorder
  • Major Depressive Episode

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline to Week 8 in Montgomery-Åsberg Depression Rating Scale (MADRS)
Secondary outcome measures
Adiponectin Level at Baseline and Week 8
Change from Baseline to Week 8 in Clinical Global Impressions Bipolar Scale (CGI-BP-S) score

Side effects data

From 2018 Phase 4 trial • 206 Patients • NCT02984982
15%
Nasopharyngitis
3%
Myocardial ischaemia
2%
Myocardial infarction
2%
Acute myocardial infarction
2%
Pneumonia
1%
Acute coronary syndrome
1%
Vascular pseudoaneurysm
1%
Rectal cancer
1%
Cardiac failure
1%
Prinzmetal angina
1%
Transient ischaemic attack
1%
Angina unstable
1%
Ventricular tachycardia
1%
Sepsis
1%
Haemorrhoids
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard of Care
Alirocumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: Bipolar I and Bipolar II DisorderExperimental Treatment1 Intervention
30 currently depressed patients with DSM-IV bipolar I or bipolar II disorder who are currently taking an adequate dose of an FDA-approved anti-manic medication will receive Bezafibrate treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bezafibrate
2013
Completed Phase 4
~510

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,929 Previous Clinical Trials
13,198,275 Total Patients Enrolled
67 Trials studying Bipolar Disorder
15,394 Patients Enrolled for Bipolar Disorder
Brain & Behavior Research FoundationOTHER
61 Previous Clinical Trials
2,784 Total Patients Enrolled
4 Trials studying Bipolar Disorder
121 Patients Enrolled for Bipolar Disorder
J Willard and Alice S. Marriott FoundationUNKNOWN
1 Previous Clinical Trials
2 Total Patients Enrolled
1 Trials studying Bipolar Disorder
2 Patients Enrolled for Bipolar Disorder

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food & Drug Administration given its stamp of approval to Bezafibrate?

"While no efficacy data has been reported yet, there are some safety reports available which resulted in the drug receiving a score of 2."

Answered by AI

Are there any open spots available for this research endeavor?

"Data on clinicaltrials.gov attests that this trial is accepting participants; the listing was initially put up on September 1st 2015 and recently refreshed on November 30th 2021."

Answered by AI

Can you elaborate on any other investigations that have utilized Bezafibrate?

"Currently, there are 4 clinical trials in progress for Bezafibrate with 1 of them being a Phase 3 study. Boston is the primary hub for such research but 82 additional sites across America are conducting these tests as well."

Answered by AI

Is geriatric participation accepted in this research initiative?

"Those aged 18 years and above, yet under 65 are eligible for this trial."

Answered by AI

May I be considered for inclusion in this research?

"This clinical trial seeks 30 individuals with manic disorder between the legal age of consent and 65 years old. Applicants have to adhere to specific conditions, including abstaining from altering their medications throughout the course of the study and meeting criteria for major depressive episode as identified by MINI diagnostic tools and having a MADRS score greater than 18 at screening and commencement. Moreover, they must not be suffering from hypomanic or manic episodes according to MINI diagnostics."

Answered by AI

How many participants are engaged in the research project?

"Affirmative. According to the information located on clinicaltrials.gov, this medical study is currently recruiting patients and has been since September 1st 2015. The trial is looking for 30 subjects at a single site."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
What site did they apply to?
The Dauten Family Center for Bipolar Treatment Innovation at Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study
Andrew A. Nierenberg, MD 2015. "BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02481245.
~3 spots leftby Apr 2025
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