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BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study

2015-06-26 06:23:23 | BioPortfolio

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 lithium 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 lithium in 20 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 lithium for acute bipolar I major depressive episodes.

In summary, we propose an 8-week, proof-of-concept open pilot trial of an adjunctive pan-PPAR agonist, bezafibrate, for 20 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Bipolar Disorder

Intervention

Bezafibrate

Status

Not yet recruiting

Source

Massachusetts General Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-06-26T06:23:23-0400

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