Could a heart drug lift bipolar depression?
NCT ID NCT02481245
First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This study tests whether bezafibrate, a drug currently used for high cholesterol, can safely improve depression in people with bipolar disorder. Thirty adults with bipolar I or II who are already on a mood-stabilizing medication will take bezafibrate for 8 weeks. Researchers will monitor mood changes, side effects, and thinking skills to see if the drug is worth testing in larger trials.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Bezafibrate (a drug used for high cholesterol, repurposed here)
- What this could lead to
- If it works, this could point toward a new treatment option for bipolar depression, especially for people who don't respond to current therapies.
- What could go wrong
- This is a very early, small, open-label trial with no placebo group, so results may not be reliable. The drug may not improve depression and could cause side effects like muscle pain or liver issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
7 people
The number who actually took part.
- Started
-
Jan 2018
- Finished
-
May 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Men or women between the ages of 18 and 65 (inclusive) 2. DSM IV diagnosis of Bipolar Disorder Type I or Bipolar Disorder Type II 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 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 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. Type 1 or Type II Diabetes requiring medication treatment treated with Pioglitazone or any other PPAR agonist medication. 14. Current use of of MAO Inhibitors, statins, and anticoagulants (e.g. warfarin)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
The Dauten Family Center for Bipolar Treatment Innovation at Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Other studies related to the condition(s) this trial covers.
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