Bezafibrate for Bipolar Disorder

Overseen By Alec P Shannon, B.S.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must be taking: Anti-manic medication

Must not be taking: MAO inhibitors, Statins, Anticoagulants

Disqualifiers: Schizophrenia, Substance use, Diabetes, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether bezafibrate, typically used for cholesterol issues, can help treat depression in individuals with bipolar disorder when added to their current medication. Researchers aim to determine its safety and effectiveness in reducing depression symptoms. Ideal participants are those experiencing a major depressive episode due to bipolar disorder and already taking anti-manic medication. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

You will need to continue taking your current FDA-approved anti-manic medication during the study. However, you cannot participate if you are currently using MAO Inhibitors, statins, or anticoagulants.

Is there any evidence suggesting that bezafibrate is likely to be safe for humans?

Research has shown that bezafibrate is under investigation for its safety and effectiveness in treating bipolar depression. Although specific safety data for bezafibrate in bipolar disorder is limited, the FDA has approved it for treating high cholesterol and triglyceride levels, indicating its general safety for those conditions.

The study aims to determine if bezafibrate can be safely used alongside existing medications for bipolar disorder. While detailed safety results from previous studies on bipolar patients are lacking, the current trial is in an early phase, focusing on initial safety in humans. Researchers are assessing how well patients tolerate the treatment and identifying any major side effects.

In summary, while bezafibrate is approved for other uses, its safety for treating bipolar depression remains under study. Trial participants will provide crucial information about its safety and tolerance in this new application. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for bipolar disorder?

Bezafibrate is unique because it's not your typical bipolar disorder treatment. Most treatments for bipolar disorder, like lithium or valproate, focus on stabilizing mood by targeting neurotransmitter activity. However, Bezafibrate works differently by affecting the metabolism of fats in the body, which is a novel approach for this condition. Researchers are excited about Bezafibrate because it has the potential to offer mood-stabilizing effects through a completely different pathway, which might benefit patients who don’t respond well to current medications.

What evidence suggests that bezafibrate might be an effective treatment for bipolar depression?

Research suggests that bezafibrate, a type of medication, might help with bipolar depression. This trial will investigate the effects of bezafibrate on 30 currently depressed patients with DSM-IV bipolar I or bipolar II disorder who are taking an adequate dose of an FDA-approved anti-manic medication. Bezafibrate influences how the body uses energy and stores fat, which could help stabilize mood. Early findings indicate that bezafibrate might reduce depressive symptoms when used alongside current anti-manic medications. Although direct evidence in humans for bipolar disorder is still developing, its effect on related biological processes supports the idea that it could be beneficial. More studies are needed to confirm its effectiveness for bipolar depression. ^{1 2 3 5 6}

Who Is on the Research Team?

Andrew A. Nierenberg, M.D.

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with Bipolar Disorder Type I or II, currently experiencing a major depressive episode. Participants must be on stable FDA-approved anti-manic medication and not planning to change it during the study. They cannot have certain other mental health diagnoses, substance use disorders, severe personality disorders, or conditions that bezafibrate could worsen.

Inclusion Criteria

Ability to sign the Informed Consent Form

Agrees not to change medications during the study

Does not meet criteria for current hypomanic or manic episode as defined and operationalized by the MINI

Exclusion Criteria

I am currently taking MAO inhibitors, statins, or anticoagulants like warfarin.

I don't have liver or bile duct problems that bezafibrate could worsen.

I have tried at least two treatments for my current bipolar depression episode without success.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bezafibrate added to FDA-approved anti-manic medication for bipolar depression

8 weeks

Weekly visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bezafibrate

Trial Overview The trial is testing bezafibrate's safety and effectiveness as an add-on treatment for bipolar depression over 8 weeks. It will monitor changes in manic symptoms, suicidal thoughts, cognitive function related to attention and verbal memory, cardiovascular risk score, and overall adverse events.

How Is the Trial Designed?

Group I: Bipolar I and Bipolar II Disorder Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Brain & Behavior Research Foundation

Collaborator

Trials

63

Recruited

2,900+

J Willard and Alice S. Marriott Foundation

Collaborator

Trials

2

Recruited

30+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02481245

BezafibrateTreatment for Bipolar Depression: A Proof of ... 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:.

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/387041

BezafibrateTreatment for Bipolar Depression: A Proof of ... We propose to test the hypothesis that bezafibrate, a pan-PPAR agonist, may be effective and safe for bipolar depression with the following ...

3. rally.massgeneralbrigham.org rally.massgeneralbrigham.org/study/beza

Try Bezafibrate - a new treatment drug for Bipolar Depression This is a new medication study that looks into whether Bezafibrate can be used as an effective drug treatment for bipolar depression.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02481245?cond=%22Mood%20Disorder%22&intr=%22Antimetabolites%22&viewType=Table&rank=6

Study Details | BezafibrateTreatment for Bipolar Depression An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6999209/

Psychopharmacology and Experimental Therapeutics for ... In this study, patients reported significant depressive or manic-hypomanic symptoms for approximately half of all follow-up weeks; weeks with depressive ...

6. ctv.veeva.com ctv.veeva.com/study/bezafibratetreatment-for-bipolar-depression-a-proof-of-concept-study

BezafibrateTreatment for Bipolar Depression: A Proof of ... 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: ...