BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar Disorder, Bezafibrate, Depressive Episode Read More

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)