12- Week Open Label Treatment of Refractory Bipolar Depression

NCT00223496 | Completed Phase 4 Results DMC

• 1 other identifier: 0340013419
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bipolar Disorder

Keywords

Bipolar Depression; Refractory

Outcome Measures

Primary Outcomes (1)

• Primary Measure:Reduction in Depression Symptoms

  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).

  up to 12 weeks

Study Arms (1)

Aripiprazole

EXPERIMENTAL

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

Drug: Aripiprazole

Interventions

Aripiprazole DRUG

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

Aripiprazole

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Univ of Texas Helath Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Charles Bowden
• Organization: UTHSCSA

Bowdenc@uthscsa.edu

210-567-5479

Study Officials

• Vivek Singh, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

• Charles L Bowden, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: September 1, 2004
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: May 16, 2017
• Results First Posted: May 21, 2013

Record last verified: 2017-04

Locations

US (1)