BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT02481245
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Bezafibrate — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 11, 2018
Status verified
Sep 2025
Primary completion
Feb 28, 2026
Completion
Feb 28, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change from Baseline to Week 8 in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Baseline and Week 8 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Dauten Family Center for Bipolar Treatment Innovation at Massachusetts General HospitalBostonMassachusetts02114
Alec P Shannon, B.S.
[email protected]
6177241858
Marina Rakhilin, B.S.
[email protected]
6176436194

Find similar trials in Boston, MA

By condition
Bipolar disorder
By specialty
PsychiatryMental healthBehavioral health
By research site
The Dauten Family Center for Bipolar Treatment Innovation at Massachusetts General Hospital· Boston, MA

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