Actively Recruiting
BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study
Led by Massachusetts General Hospital · Updated on 2025-10-03
30
Participants Needed
1
Research Sites
424 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
B
Brain & Behavior Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
We propose to test the hypothesis that bezafibrate, a pan-PPAR agonist, may be effective and safe for bipolar depression with the following specific aims: Aim #1. Proof-of-Concept Safety and Tolerability Aim: To assess the safety and tolerability of bezafibrate added to anti-manic medication for bipolar depression, especially with regard to worsening manic symptoms and suicidal ideation. We will conduct a phase IIa, 8-week, open pilot trial of bezafibrate added to FDA-approved anti-manic medication in 30 participants with bipolar depression. We will monitor changes in manic symptoms (Young Mania Rating Scale), suicidal ideation, cognitive functioning specifically in attention and verbal memory, and treatment emergent adverse events (SAFTEE). We will also monitor changes in the Framingham Cardiovascular Risk Score. Aim #2. Preliminary Assessment of Efficacy: To assess the antidepressant efficacy of bezafibrate added to anti-manic medication for acute bipolar I major depressive episodes. Hypothesis: The bezafibrate group will have a statistically significant decrease in the Montgomery Asberg Rating Scale (MADRS) Scores over 8 weeks. The results of this proof-of concept phase IIa study will help us to plan a placebo-controlled randomized trial. In summary, we propose an 8-week, proof-of-concept open pilot trial of an adjunctive pan-PPAR agonist, bezafibrate, for 30 patients with an acute bipolar I major depressive episode. The study may have a profound impact on the development of a novel treatment consistent with the mitochondrial dysregulation hypothesis of bipolar disorder and, to the best of our knowledge, will be the first proof-of-concept trial to assess a pan-PPAR agonist for bipolar disorder.
CONDITIONS
Official Title
BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women between the ages of 18 and 65 (inclusive)
- Diagnosis of Bipolar Disorder Type I or Type II according to DSM IV
- Ability to sign the Informed Consent Form
- Taking an adequate dose of any FDA-approved anti-manic medication for at least two weeks prior to enrollment
- Agrees not to change medications during the study
- Meets criteria for a current major depressive episode with a MADRS score greater than 18 at screening and baseline
- Does not meet criteria for a current hypomanic or manic episode
You will not qualify if you...
- Bipolar NOS, Cyclothymia, Schizoaffective Disorder, organic mental disorders, substance use disorders active within 3 months, schizophrenia, delusional disorder, psychotic disorders not elsewhere classified, acute bereavement, severe borderline or antisocial personality disorder, OCD or OCD-spectrum disorders
- Primary diagnosis of anxiety disorders or anxiety as the primary focus of treatment
- Presence of mood congruent or incongruent psychotic features
- Pregnant women or women of childbearing potential not using accepted contraception; nursing women
- Serious suicide or homicide risk
- Unstable systemic medical disorders including epilepsy, untreated endocrine disease, unstable angina, recent ulcers or significant esophagitis
- Conditions worsened by bezafibrate such as hepatobiliary disease
- Hypothyroidism unless euthyroid for at least 1 month on thyroid medication
- Failure of two or more somatic therapy trials during current bipolar depressive episode
- Current use or history of intolerance to fibrates
- History of significant treatment non-adherence
- History of stroke or cerebrovascular disease
- Type 1 or Type II Diabetes treated with Pioglitazone or other PPAR agonists
- Current use of MAO inhibitors, statins, or anticoagulants (e.g., warfarin)
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Dauten Family Center for Bipolar Treatment Innovation at Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
A
Alec P Shannon, B.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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