Bipolar DisorderPhase 2NCT02481245
BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study
A Phase 2 study testing Bezafibrate in people with Bipolar Disorder and Depressive Episode, run by Massachusetts General Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, Depressive Episode
- What is being tested?
- Bezafibrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2018to 26 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Patients with mood congruent or mood incongruent psychotic features
- 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
- Patients who are a serious suicide or homicide risk
- Suspected or known clinically unstable systemic medical disorder including epilepsy, untreated endocrine disease, unstable angina, recent ulcers or significant esophagitis
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- Conditions which may be negatively affected by bezafibrate treatment, such as hepatobiliary disease
- Clinical or laboratory evidence of hypothyroidism (if maintained on thyroid medication must be euthyroid for at least 1 month before Visit 1)
- 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
- 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
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Dauten Family Center for Bipolar Treatment Innovation at Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Pan-PPAR Agonist Treatment 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 bipolar depression, especially with regard to worsening manic symptoms and suicidal ideation.
Read more
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
- Bipolar Disorder, Depressive Episode
- Being tested
- Bezafibrate
- Keywords
- Bipolar Disorder, Bezafibrate, Depressive Episode
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BezafibrateDrug
Also called Bezalip
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 group | Role | What they receive |
|---|---|---|
| Bipolar I and Bipolar II Disorder | Experimental | 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. Receives: Drug: Bezafibrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Week 8 in Montgomery-Åsberg Depression Rating Scale (MADRS)
The primary efficacy measure will be the change in MADRS score.
Measured: Baseline and Week 8
Secondary outcomes (2)
Change from Baseline to Week 8 in Clinical Global Impressions Bipolar Scale (CGI-BP-S) score
Secondary efficacy measure will be change in CGI-BP-S score.
Measured: Baseline and Week 8
Adiponectin Level at 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.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study start11 Jan 2018
- Primary completion26 May 2026
- Study completion26 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brain & Behavior Research Foundation, J Willard and Alice S. Marriott Foundation
- Responsible party
- Principal investigator, Andrew A. Nierenberg, MD, Massachusetts General Hospital
- Investigators
- Andrew A. Nierenberg, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481245
- Sponsor's protocol ID
- 2014P000862
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2015
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Identifiable, individual-level data will not be shared. Deidentified group-level data will be published/presented after study completion and analysis.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pan-PPAR Agonist Treatment for Bipolar Depression: A Proof of Concept Study
- ClinicalTrials.gov ID
- NCT02481245
- Acronym / sponsor ID
- 2014P000862
- Conditions
- Bipolar Disorder, Depressive Episode
- Keywords
- Bipolar Disorder, Bezafibrate, Depressive Episode
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Brain & Behavior Research Foundation, J Willard and Alice S. Marriott Foundation
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 26 May 2026 (actual)
- Study completion
- 26 May 2026 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bipolar I and Bipolar II Disorder | Experimental | Drug: Bezafibrate30 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
- Patients with mood congruent or mood incongruent psychotic features
- 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
- Patients who are a serious suicide or homicide risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BezafibrateAlso: Bezalip30 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. | Drug | Bipolar I and Bipolar II Disorder |
Primary outcome
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.
2 secondary outcomes
Change from Baseline to Week 8 in Clinical Global Impressions Bipolar Scale (CGI-BP-S) score
Time frame: Baseline and Week 8
Adiponectin Level at Baseline and Week 8
Time frame: Baseline and Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No. Identifiable, individual-level data will not be shared. Deidentified group-level data will be published/presented after study completion and analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew A. Nierenberg, M.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bezafibrate in people with Bipolar Disorder and Depressive Episode, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to Week 8 in Montgomery-Åsberg Depression Rating Scale (MADRS) (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.