BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study
Status:
Recruiting
Trial end date:
2020-06-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Massachusetts General Hospital
Collaborators:
Brain & Behavior Research Foundation J Willard and Alice S. Marriott Foundation