We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

12- Week Open Label Treatment of Refractory Bipolar Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00223496
First Posted: September 22, 2005
Last Update Posted: May 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Charles L. Bowden, The University of Texas Health Science Center at San Antonio
  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: Intervention Model: Single Group Assignment
Masking: None (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 Charles L. Bowden, 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 ]
    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.

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Charles L. Bowden, Principal Investigator, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00223496     History of Changes
Other Study ID Numbers: 0340013419
First Submitted: September 14, 2005
First Posted: September 22, 2005
Results First Submitted: February 27, 2013
Results First Posted: May 21, 2013
Last Update Posted: May 16, 2017
Last Verified: April 2017

Keywords provided by Charles L. Bowden, The University of Texas Health Science Center at San Antonio:
Bipolar Depression
Refractory

Additional relevant MeSH terms:
Depression
Bipolar Disorder
Behavioral Symptoms
Bipolar and Related Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs