12- Week Open Label Treatment of Refractory Bipolar Depression

Phase 4

Completed

• Conditions: Bipolar Disorder
• Interventions: Drug: Aripiprazole

• Registration Number: NCT00223496
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief 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

Detailed 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

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2013-02-27
• Results First Submitted QC: 2013-04-09
• Results First Posted: 2013-05-21
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Primary Measure:Reduction in Depression Symptoms	up to 12 weeks	Primary efficacy will be assessed by the proportion of patients achieving a 50% reduction (range 0- 60, higher the number the more depressed) on the Montgomery Asberg Depression Rating Scale (MADRS) (defined as response) concomitant with a Clinical Global Impression Scale(CGI-S) improvement of 1 or 2 (range 0-7, higher the number the more severe the overall bipolar symptoms).

Trial Locations

Locations (1)

Univ of Texas Helath Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States