12- Week Open Label Treatment of Refractory Bipolar Depression

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborator: Bristol-Myers Squibb
• Treatments: Aripiprazole

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