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Trial record 1 of 1604 for:    bipolar
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BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study

This study is currently recruiting participants.
Verified September 2017 by Andrew A. Nierenberg, MD, Massachusetts General Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02481245
First Posted: June 25, 2015
Last Update Posted: September 11, 2017
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.
Collaborators:
Brain & Behavior Research Foundation
The J. Willard and Alice S. Marriott Foundation
Information provided by (Responsible Party):
Andrew A. Nierenberg, MD, Massachusetts General Hospital
  Purpose

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 Intervention Phase
Bipolar Disorder Depressive Episode Drug: Bezafibrate Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pan-PPAR Agonist Treatment for Bipolar Depression: A Proof of Concept Study

Resource links provided by NLM:


Further study details as provided by Andrew A. Nierenberg, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 30
Study Start Date: September 2015
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bipolar I Disorder
30 currently depressed patients with DSM-IV bipolar I disorder who are currently taking an adequate dose of an FDA-approved anti-manic medication will receive Bezafibrate treatment
Drug: Bezafibrate
30 patients with Bipolar I 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men or women between the ages of 18 and 65 (inclusive)
  2. DSM IV diagnosis of Bipolar Disorder Type I
  3. Ability to sign the Informed Consent Form
  4. Taking an adequate dose of any FDA-approved anti-manic medication for at least two weeks prior to enrollment
  5. Agrees not to change medications during the study
  6. 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)
  7. Does not meet criteria for current hypomanic or manic episode as defined and operationalized by the MINI

Exclusion Criteria:

  1. The following DSM-IV diagnoses: (1) Bipolar II, (2) Bipolar NOS, (3) Cyclothymia, (4) Schizoaffective Disorder, (5) organic mental disorders, (6) substance use disorders, including alcohol, active within the 3 months, (7) schizophrenia, (8) delusional disorder, (9) psychotic disorders not elsewhere classified, (10) acute bereavement, (11) severe borderline or antisocial personality disorder, (12) OCD or OCD-spectrum disorders
  2. Primary diagnosis of anxiety disorders or patients where the anxiety disorder is the primary focus of treatment
  3. Patients with mood congruent or mood incongruent psychotic features
  4. 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
  5. Patients who are a serious suicide or homicide risk
  6. Suspected or known clinically unstable systemic medical disorder including epilepsy, untreated endocrine disease, unstable angina, recent ulcers or significant esophagitis
  7. Conditions which may be negatively affected by bezafibrate treatment, such as hepatobiliary disease
  8. Clinical or laboratory evidence of hypothyroidism (if maintained on thyroid medication must be euthyroid for at least 1 month before Visit 1)
  9. 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
  10. Current use of a fibrate or history of anaphylactic reaction or intolerance to fibrates or any component of the preparation
  11. History of significant treatment non-adherence or situations where the subjects is unlikely to adhere to treatment, in the opinion of the investigator
  12. History of stroke or cerebrovascular disease
  13. History of Type 1 or Type II Diabetes
  14. Current use of of MAO Inhibitors, statins, and anticoagulants (e.g. warfarin)
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Steven Dufour, B.A. 617-643-6194 sdufour@partners.org

Locations
United States, Massachusetts
The Dauten Family Center for Bipolar Treatment Innovation at Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Steven Dufour, B.A.    617-643-6194    sdufour@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Brain & Behavior Research Foundation
The J. Willard and Alice S. Marriott Foundation
Investigators
Principal Investigator: Andrew A. Nierenberg, M.D. Massachusetts General Hospital
  More Information

Responsible Party: Andrew A. Nierenberg, MD, Director, Dauten Family Center for Bipolar Treatment Innovation, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02481245     History of Changes
Other Study ID Numbers: 2014P000862
First Submitted: June 23, 2015
First Posted: June 25, 2015
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Identifiable, individual-level data will not be shared. Deidentified group-level data will be published/presented after study completion and analysis.

Keywords provided by Andrew A. Nierenberg, MD, Massachusetts General Hospital:
Bipolar Disorder
Bezafibrate
Depressive Episode

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Bezafibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents