12- Week Open Label Treatment of Refractory Bipolar Depression
Bipolar Disorder
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar Depression, Refractory
Eligibility Criteria
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
Sites / Locations
- Univ of Texas Helath Science Center at San Antonio
Arms of the Study
Arm 1
Experimental
Aripiprazole
Aripiprazole open-label in doses ranging from 5-30mg QD adjunct to Divalproex 500-2500mg QD.