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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bipolar Disorder
Intervention Drug: Aripiprazole
Enrollment 32
Recruitment Details Recruitment from March 2006 to June 2009 from clinic patients and those responding to public advertisements.
Pre-assignment Details Subjects who entered study in a bipolar depressed state were started on divalproex ER. Those still depressed, according to depression rating scales, after visit 4 were given aripiprazole in addition to divalproex ER.
Arm/Group Title Aripiprazole Plus Divalproex ER
Hide Arm/Group Description Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
Period Title: Overall Study
Started 32 [1]
Completed 10
Not Completed 22
Reason Not Completed
screen failure             9
Lost to Follow-up             4
Lack of Efficacy             6
Withdrawal by Subject             1
Physician Decision             2
[1]
32 people consented, 19 were baselined
Arm/Group Title Aripiprazole
Hide Arm/Group Description Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
32 subjects consented, 19 subjects were baselined
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
<=18 years
0
   0.0%
Between 18 and 65 years
19
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants
41  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
13
  68.4%
Male
6
  31.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants
19
1.Primary Outcome
Title Primary Measure:Reduction in Depression Symptoms
Hide Description 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).
Time Frame up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aripiprazole Plus Divalalproex ER
Hide Arm/Group Description:
Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: participants
16
Time Frame 3-31-2006 to 9-11-2009, 3 yrs 6 mo
Adverse Event Reporting Description Patient reporting and systematic questioning
 
Arm/Group Title Aripiprazole Plus Divalproex ER
Hide Arm/Group Description Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
All-Cause Mortality
Aripiprazole Plus Divalproex ER
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Aripiprazole Plus Divalproex ER
Affected / at Risk (%) # Events
Total   0/19 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aripiprazole Plus Divalproex ER
Affected / at Risk (%) # Events
Total   6/16 (37.50%)    
Nervous system disorders   
Akathisia  [1]  6/16 (37.50%)  6
Indicates events were collected by systematic assessment
[1]
a feeling of restlessness that results in movements of body parts.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Charles Bowden
Organization: UTHSCSA
Phone: 210-567-5479
EMail: Bowdenc@uthscsa.edu
Layout table for additonal information
Responsible Party: Charles L. Bowden, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00223496    
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