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

Inclusion Criteria: The protocol is designed to collect evidence from subjects during thecourse of routine clinical care. Enrollment is limited to consenting subjects with acurrent local care provider who agrees that oxcarbazepine is a reasonable next step inmanaging their bipolar depression

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 episodemeeting criteria for MDE with or without mixed features according to the Diagnosticand Statistical Manual of Mental Disorders, 5th Edition (DSM-5) at screen and baselineand confirmed by the Collaborative Care Initiative (CCI) review of pre-assessmentincluding bipolarity index score ≥ 50,

4. Severity of current MDE at least moderate depression as defined by Montgomery AsbergDepression Rating Scale (MADRS) ≥20 and least three symptoms of DSM 5 MDE criteriameet threshold for counting toward a current MDE diagnosis (item scores ≥4) at screenand 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 ofthree acceptable medication types, but no more than 1 from each class: lithium, onedopamine-blocking agent, one standard antidepressant medication.

8. The LCP agrees that treatment with oxcarbazepine is appropriate, completes studytraining, and agrees to complete all protocol management and record keepingrequirements.

9. Any urine toxicology screens for drugs of abuse (cocaine, amphetamines, barbiturates,opiates, benzodiazepines, and cannabinoids) and alcohol in the 6 months prior to thebaseline visit have been negative. Note any positive test result(s) forbenzodiazepines accompanied by confirmation of a prescription for a valid medicalreason 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 studydrug administration) or at least one year post-menopausal, must have used an effectivemethod of avoiding pregnancy (including oral, transdermal, or implanted contraceptivesintrauterine 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 leastfour weeks prior to study drug administration, and must have agreed to continue usingsuch precautions through the End of Study visit. Cessation of birth control after thispoint was to be discussed with a responsible physician.

12. At least one set of clinical labs including serum sodium, creatinine and TSH have beenobtained and within normal limits within the 3 months prior to the baseline visit.

Exclusion Criteria:

1. Inability to provide informed consent in English

2. Current or lifetime diagnosis of epilepsy

3. Pregnancy, breastfeeding or refusal to use birth control

4. Another current Axis I diagnosis that is the primary focus of current treatment

5. Substance or alcohol abuse/dependence at least 6 months prior enrollment

6. Clinically significant abnormal results on clinical laboratories (including serumCreatinine, Sodium, and TSH) at baseline visit or within the prior 3 months.

7. Has started treatment with an FDA approved agent for Bipolar depression within thepast 4 weeks

8. Has received treatment with a long-acting injectable antipsychotic orelectroconvulsive therapy during the 2 months prior screening

9. If psychotropic medication outside of study limits is required (Note: Subjects mayreceive any concomitant medications prescribed by their local care providers with thefollowing specific exceptions: Anti-anxiety medications (anxiolytics) exceedingequivalent of lorazepam 2 mg/d.

10. Any long-acting injectable antipsychotic, More than one dopamine blocking agent, Morethan one standard antidepressant agent, FDA approved treatments for Bipolar depression (quetiapine, lurasidone, the combination of olanzapine and fluoxetine), orElectroconvulsive therapy.)

11. Last dose of another anticonvulsant agent taken in the current week or within 5half-lives of discontinuation (whichever is longer) prior to enrollment in the study

12. Current treatment requires ongoing anti-anxiety medications (Anxiolytics) exceedingequivalent of lorazepam 2 mg/d.

13. Use of oxcarbazepine (OXC) for treatment of current episode

14. Previous known hypersensitivity to OXC or other related drugs, such as carbamazepine.

15. History or presence of clinically significant, chronic medical condition, (e.g.,hyponatremia, any neurological, gastrointestinal, endocrine, cardiovascular,pulmonary, hematological, immunologic, renal, hepatic or metabolic disease) that inthe opinion of the clinician or investigator may affect the safety of the subject andthe participation to the trial.

16. Active Suicidality (MADRS item 10 >4) Active suicidal plan/intent or active suicidalthoughts in the past 6 months. Any suicide attempt within two years of the screeningassessment.