BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02481245
Study type	Interventional
Source	Massachusetts General Hospital
Contact	Alec P Shannon, B.S.
Phone	6177241858
Email	apshannon@mgh.harvard.edu
Status	Recruiting
Phase	Phase 2
Start date	September 2015
Completion date	June 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05111548` - Brain Stimulation and Cognitive Training - Efficacy	N/A
Completed	`NCT02855762` - Targeting the Microbiome to Improve Clinical Outcomes in Bipolar Disorder	N/A
Recruiting	`NCT05915013` - Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response	Phase 1
Recruiting	`NCT05206747` - Ottawa Sunglasses at Night for Mania Study	N/A
Completed	`NCT02513654` - Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects	Phase 1
Recruiting	`NCT06313918` - Exercise Therapy in Mental Disorders-study	N/A
Completed	`NCT02304432` - Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine	Early Phase 1
Recruiting	`NCT06197048` - Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder	N/A
Completed	`NCT03497663` - VIA Family - Family Based Early Intervention Versus Treatment as Usual	N/A
Completed	`NCT04284813` - Families With Substance Use and Psychosis: A Pilot Study	N/A
Completed	`NCT02212041` - Electronic Cigarettes in Smokers With Mental Illness	N/A
Recruiting	`NCT05030272` - Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings	N/A
Recruiting	`NCT04298450` - ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention	N/A
Active, not recruiting	`NCT03641300` - Efficacy of Convulsive Therapies for Bipolar Depression	N/A
Not yet recruiting	`NCT04432116` - Time and Virtual Reality in Schizophrenia and Bipolar Disorder	N/A
Terminated	`NCT02909504` - Gao NARASD Lithium Study	Phase 4
Terminated	`NCT02893371` - Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
Completed	`NCT02970721` - Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
Recruiting	`NCT03088657` - Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study
Completed	`NCT02560701` - High Deductible Health Plans and Bipolar Disorder