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12- Week Open Label Treatment of Refractory Bipolar Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by The University of Texas Health Science Center at San Antonio.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00223496
First received: September 14, 2005
Last updated: April 18, 2007
Last verified: April 2007
History of Changes
  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
Drug: Divalproex ER
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Primary Measure: Primary efficacy will be assessed by the proportion of patients achieving a 50% reduction on the MADRS (defined as response) concomitant with a CGI-S improvement of 1 or 2.

Secondary Outcome Measures:
  • Secondary Measures: This will include changes in the MADRS and GAF. Safety will be monitored by the Simpson Angus scale and Barnes Akathisia scale, lipid profile and CBC.

Estimated Enrollment: 20
Study Start Date: September 2004
Estimated Study Completion Date: March 2009
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 MINI
  • 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 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 DEP
  • 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 AZP
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00223496

Contacts
Contact: Martha - Dahl, RN 210-567-5501 dahlml@uthscsa.edu

Locations
United States, Texas
Univ of Texas Helath Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Martha - Dahl, RN            
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

ClinicalTrials.gov Identifier: NCT00223496     History of Changes
Other Study ID Numbers: 0340013419
Study First Received: September 14, 2005
Last Updated: April 18, 2007
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
Mood Disorders
Mental Disorders
Behavioral Symptoms
Aripiprazole
 Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 16, 2013