12- Week Open Label Treatment of Refractory Bipolar Depression

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Bipolar Disorder

Treatments: Drug: Aripiprazole

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00223496

0340013419

Details and patient eligibility

About

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

Full description

)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

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

32 participants in 1 patient group

Aripiprazole

Experimental group

Description:

Aripiprazole open-label in doses ranging from 5-30mg QD adjunct to Divalproex 500-2500mg QD.

Treatment:

Drug: Aripiprazole