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12- Week Open Label Treatment of Refractory Bipolar Depression

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Vivek Singh, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00223496
First received: September 14, 2005
Last updated: April 9, 2013
Last verified: April 2013
  Purpose
  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

Condition Intervention Phase
Bipolar Disorder
Drug: Aripiprazole
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 12- Week Open Label Treatment of Refractory Bipolar Depression (BD) With Combination of Depakote ER (DEP) and Aripiprazole (AZP)

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Primary Measure:Reduction in Depression Symptoms [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    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).


Enrollment: 32
Study Start Date: September 2004
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aripiprazole
Aripiprazole open-label in doses ranging from 5-30mg QD adjunct to Divalproex 500-2500mg QD.
Drug: Aripiprazole
Aripiprazole5mg - 30mg, every day (QD), for 12 weeks.
Other Name: aripiprazole

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223496

Locations
United States, Texas
Univ of Texas Helath Science Center at San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Bristol-Myers Squibb
Investigators
Principal Investigator: Vivek - Singh, MD University of Texas
Principal Investigator: Charles L Bowden, MD University of Texas
  More Information

No publications provided

Responsible Party: Vivek Singh, Principal Investigator, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00223496     History of Changes
Other Study ID Numbers: 0340013419
Study First Received: September 14, 2005
Results First Received: February 27, 2013
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center at San Antonio:
Bipolar Depression
Refractory

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Behavioral Symptoms
Mental Disorders
Mood Disorders
Aripiprazole
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014