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New treatment option for Bipolar Disorder
Official title BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study
ClinicalTrials.gov ID: NCT02481245
What this study is testing
What is Bezafibrate?
Bezafibrate is an investigational medicine, given as an once-daily, being studied as a potential treatment for bipolar disorder.
Also referred to as Bezalip.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 8 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- The following DSM-IV diagnoses: (1) Bipolar NOS, (2) Cyclothymia, (3) Schizoaffective Disorder, (4) organic mental disorders, (5) substance use...
- 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...
- 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...
See the full eligibility criteria
- 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
- 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)...
- 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...
- 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
- 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)
- people 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 people 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)
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.