BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study

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)