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NCT02481245 · ClinicalTrials.gov registry record · Phase 2
BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study
A Phase 2 study of Bipolar Disorder and Depressive Episode, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT02481245 is a Phase 2 study of Bipolar Disorder and Depressive Episode that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 30 participants, below the 333-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02481245, a Phase 2 study of Bipolar Disorder and Depressive Episode, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Bezafibrate
Study Locations (1)
Massachusetts
- The Dauten Family Center for Bipolar Treatment Innovation at Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-01-11 |
| Est. Completion | 2026-02-28 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02481245
The ClinicalTrials.gov registry entry for NCT02481245 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 333-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (91% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Bipolar Disorder appearing as the primary indexed condition, and to 1 intervention - of which Bezafibrate is the first listed.
NCT02481245 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02481245 about?
NCT02481245 is a clinical study titled "BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study". 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 bi...
What is the current status of trial NCT02481245?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2018-01-11. Estimated completion is 2026-02-28.
What conditions does trial NCT02481245 study?
This clinical trial studies the following conditions: Bipolar Disorder, Depressive Episode.
What interventions are being tested in trial NCT02481245?
The interventions under investigation include: Bezafibrate (DRUG).
Who is sponsoring clinical trial NCT02481245?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02481245 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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