12- Week Open Label Treatment of Refractory Bipolar Depression

NCT ID: NCT00223496

Last Updated: 2017-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2009-09-30

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

Conditions

Bipolar Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aripiprazole

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

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Aripiprazole5mg - 30mg, every day (QD), for 12 weeks.

Interventions

Aripiprazole

Aripiprazole5mg - 30mg, every day (QD), for 12 weeks.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Charles L. Bowden

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vivek Singh, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Charles L Bowden, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

Univ of Texas Helath Science Center at San Antonio

San Antonio, Texas, United States

Countries

United States

Other Identifiers

0340013419

Identifier Type: -

Identifier Source: org_study_id