BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02481245|
Recruitment Status : Recruiting
First Posted : June 25, 2015
Last Update Posted : December 6, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Depressive Episode||Drug: Bezafibrate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pan-PPAR Agonist Treatment for Bipolar Depression: A Proof of Concept Study|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: Bipolar I and Bipolar II Disorder
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.
30 patients with Bipolar I or Bipolar II disorder who are experiencing an acute bipolar depressive episode will be given bezafibrate XR 400 mg daily added on to adequate doses of an FDA-approved anti-manic medication.
Other Name: Bezalip
- Change from Baseline to Week 8 in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Baseline and Week 8 ]The primary efficacy measure will be the change in MADRS score.
- Change from Baseline to Week 8 in Clinical Global Impressions Bipolar Scale (CGI-BP-S) score [ Time Frame: Baseline and Week 8 ]Secondary efficacy measure will be change in CGI-BP-S score.
- Adiponectin Level at Baseline and Week 8 [ Time Frame: Baseline and Week 8 ]We will measure adiponectin as a well-established biomarker for the effect of bezafibrate on PPAR and examine changes in adiponectin as a mediator of changes in mood symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481245
|Contact: Alec P Shannon, B.S.||email@example.com|
|United States, Massachusetts|
|The Dauten Family Center for Bipolar Treatment Innovation at Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Alec P Shannon, B.S. 617-724-1858 firstname.lastname@example.org|
|Contact: Marina Rakhilin, B.S. 6176436194 email@example.com|
|Principal Investigator:||Andrew A. Nierenberg, M.D.||Massachusetts General Hospital|