search
Back to results

12- Week Open Label Treatment of Refractory Bipolar Depression

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar Depression, Refractory

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Univ of Texas Helath Science Center at San Antonio

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aripiprazole

Arm Description

Aripiprazole open-label in doses ranging from 5-30mg QD adjunct to Divalproex 500-2500mg QD.

Outcomes

Primary Outcome Measures

Primary Measure:Reduction in Depression Symptoms
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).

Secondary Outcome Measures

Full Information

First Posted
September 14, 2005
Last Updated
April 19, 2017
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Bristol-Myers Squibb
search

1. Study Identification

Unique Protocol Identification Number
NCT00223496
Brief Title
12- Week Open Label Treatment of Refractory Bipolar Depression
Official Title
12- Week Open Label Treatment of Refractory Bipolar Depression (BD) With Combination of Depakote ER (DEP) and Aripiprazole (AZP)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Determine the change in symptomatology and function in refractory bipolar depression, when treated with combination of DEP+AZP for a period of 12 weeks 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar Depression, Refractory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aripiprazole
Arm Type
Experimental
Arm Description
Aripiprazole open-label in doses ranging from 5-30mg QD adjunct to Divalproex 500-2500mg QD.
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Intervention Description
Aripiprazole5mg - 30mg, every day (QD), for 12 weeks.
Primary Outcome Measure Information:
Title
Primary Measure:Reduction in Depression Symptoms
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivek Singh, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles L Bowden, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univ of Texas Helath Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

12- Week Open Label Treatment of Refractory Bipolar Depression

We'll reach out to this number within 24 hrs