BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study

Inclusion 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

Exclusion criteria

• 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
• 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)