12- Week Open Label Treatment of Refractory Bipolar Depression

)Determine the change in symptomatology and function in refractory bipolar depression, when treated with combination of DEP+AZP for a period of 12 weeks

• Determine the tolerability and safety of AZP added to DEP in the treatment of refractory bipolar depression

Inclusion criteria

• diagnosis of bipolar disorder I or II according to M.I.N.I.
• patient has signed informed consent
• male, or female who is using effective birth control if of child bearing age
• age 18 and above
• currently in a depressed phase, with or without psychotic features, of the illness based on DSM-IV/MINI criteria
• score of more than 19 on the MADRS
• history of treatment refractory bipolar depression as defined by failure of the depressive episode to respond to a mood stabilizer alone or a combination of 2 or more mood stabilizers or a combination of a mood stabilizer and an antidepressant

Exclusion criteria

• current liver disease,
• illness precluding the use of depakote er
• patients who have been treated with a DEP and AZP combination in the past
• Alcohol/drug dependence in the past one month
• CNS neoplasms, demyelinating diseases, degenerative neurological condition or active CNS infection
• history of seizure, known EEG with frank paroxysmal activity, known CT of brain showing gross structural abnormalities, cerebral vascular disease by history or structural brain damage from trauma
• thyroid dysfunction
• unstable general medical condition
• require antipsychotic other than abilify