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12- Week Open Label Treatment of Refractory Bipolar Depression

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.
 
ClinicalTrials.gov Identifier: NCT00223496
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : May 21, 2013
Last Update Posted : May 16, 2017
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Charles L. Bowden, The University of Texas Health Science Center at San Antonio

Tracking Information
First Submitted Date  ICMJE September 14, 2005
First Posted Date  ICMJE September 22, 2005
Results First Submitted Date  ICMJE February 27, 2013
Results First Posted Date  ICMJE May 21, 2013
Last Update Posted Date May 16, 2017
Study Start Date  ICMJE September 2004
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2013)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 12- Week Open Label Treatment of Refractory Bipolar Depression
Official Title  ICMJE 12- Week Open Label Treatment of Refractory Bipolar Depression (BD) With Combination of Depakote ER (DEP) and Aripiprazole (AZP)
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bipolar Disorder
Intervention  ICMJE Drug: Aripiprazole
Aripiprazole5mg - 30mg, every day (QD), for 12 weeks.
Study Arms  ICMJE Experimental: Aripiprazole
Aripiprazole open-label in doses ranging from 5-30mg QD adjunct to Divalproex 500-2500mg QD.
Intervention: Drug: Aripiprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2013)
32
Original Enrollment  ICMJE
 (submitted: September 14, 2005)
20
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00223496
Other Study ID Numbers  ICMJE 0340013419
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Charles L. Bowden, The University of Texas Health Science Center at San Antonio
Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Principal Investigator: Vivek Singh, MD University of Texas
Principal Investigator: Charles L Bowden, MD University of Texas
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP