Comparison of Two Forms of Oxcarbazepine for the Treatment of Bipolar Depression

Inclusion Criteria

• •1. Adults male or female, 18-65 years of age, inclusive, at the time of informed consent.
• •2. Able to access the internet for computer administered ratings.
• •3. Lifetime mood disorder Diagnosis of Bipolar disorder I or II and a current episode meeting criteria for MDE with or without mixed features according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) at screen and baseline and confirmed by the Collaborative Care Initiative (CCI) review of pre-assessment including bipolarity index score ≥ 50,
• •4. Severity of current MDE at least moderate depression as defined by Montgomery Asberg Depression Rating Scale (MADRS) ≥20 and least three symptoms of DSM 5 MDE criteria meet threshold for counting toward a current MDE diagnosis (item scores ≥4) at screen and baseline.
• •5. Duration of current MDE at baseline is at least 4 weeks in and no longer than 2 years
• •6. Cycle frequency does not exceed 8 mood episodes in the past 365 days.
• •7. Current treatment regimen stable for at least 4 weeks and must include at least one of three acceptable medication types, but no more than 1 from each class: lithium, one dopamine-blocking agent, one standard antidepressant medication.
• •8. The LCP agrees that treatment with oxcarbazepine is appropriate, completes study training, and agrees to complete all protocol management and record keeping requirements.
• •9. Any urine toxicology screens for drugs of abuse (cocaine, amphetamines, barbiturates, opiates, benzodiazepines, and cannabinoids) and alcohol in the 6 months prior to the baseline visit have been negative. Note any positive test result(s) for benzodiazepines accompanied by confirmation of a prescription for a valid medical reason will be allowed.
• •10. Negative urine pregnancy test at screen or baseline visit.
• •11. Sexually active women, unless surgically sterile (at least six months prior to study drug administration) or at least one year post-menopausal, must have used an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, abstinence, use of condom with spermicide by sexual partner or sterile \[at least six months prior to study drug administration\] sexual partner) for at least four weeks prior to study drug administration, and must have agreed to continue using such precautions through the End of Study visit. Cessation of birth control after this point was to be discussed with a responsible physician.
• •12. At least one set of clinical labs including serum sodium, creatinine and TSH have been obtained and within normal limits within the 3 months prior to the baseline visit.