NCT02481245CompletedPhase 2
BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study
A Pan-PPAR Agonist Treatment for Bipolar Depression: A Proof of Concept Study
Source: ClinicalTrials.gov · Last updated 24 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 7 (actual)
- First submitted
- 23 Jun 2015
- Start date
- 11 Jan 2018
- Primary completion date
- 26 May 2026
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Bipolar disorder
- NCT number
- NCT02481245
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 7
- From 11 Jan 2018 to the primary completion date, 26 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (e.g. oral contraceptives, intrauterine device, barrier methods, or total abstinence from intercourse; Depo Provera is acceptable if it is started 3 months prior to enrollment). Women who are nursing
- Subjects having failed two or more trials of somatic therapy (i.e., medications for bipolar depression or FDA-approved devices) during the current bipolar depressive episode
- Type 1 or Type II Diabetes requiring medication treatment treated with Pioglitazone or any other PPAR agonist medication.
- Current use of of MAO Inhibitors, statins, and anticoagulants (e.g. warfarin)
Other illness
- The following DSM-IV diagnoses: (1) Bipolar NOS, (2) Cyclothymia, (3) Schizoaffective Disorder, (4) organic mental disorders, (5) substance use disorders, including alcohol, active within the 3 months, (6) schizophrenia, (7) delusional disorder, (8) psychotic disorders not elsewhere classified, (9) acute bereavement, (10) severe borderline or antisocial personality disorder, (11) OCD or OCD-spectrum disorders
- Primary diagnosis of anxiety disorders or patients where the anxiety disorder is the primary focus of treatment
- Suspected or known clinically unstable systemic medical disorder including epilepsy, untreated endocrine disease, unstable angina, recent ulcers or significant esophagitis
- Conditions which may be negatively affected by bezafibrate treatment, such as hepatobiliary disease
- Current use of a fibrate or history of anaphylactic reaction or intolerance to fibrates or any component of the preparation
- History of significant treatment non-adherence or situations where the subjects is unlikely to adhere to treatment, in the opinion of the investigator
- History of stroke or cerebrovascular disease
Lab values
- Clinical or laboratory evidence of hypothyroidism (if maintained on thyroid medication must be euthyroid for at least 1 month before Visit 1)
Other
- Patients with mood congruent or mood incongruent psychotic features
- Patients who are a serious suicide or homicide risk
Who the study is looking for
- Men or women between the ages of 18 and 65 (inclusive)
- DSM IV diagnosis of Bipolar Disorder Type I or Bipolar Disorder Type II
- Ability to sign the Informed Consent Form
- Taking an adequate dose of any FDA-approved anti-manic medication for at least two weeks prior to enrollment
- Agrees not to change medications during the study
- Meets criteria for a current major depressive episode as defined and operationalized by the MINI and by a MADRS score of \>18 at screen and baseline (randomization)
- Does not meet criteria for current hypomanic or manic episode as defined and operationalized by the MINI
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Dauten Family Center for Bipolar Treatment Innovation at Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.