12- Week Open Label Treatment of Refractory Bipolar Depression

April 19, 2017 updated by: Charles L. Bowden, The University of Texas Health Science Center at San Antonio

12- Week Open Label Treatment of Refractory Bipolar Depression (BD) With Combination of Depakote ER (DEP) and Aripiprazole (AZP)

  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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • Univ of Texas Helath Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: Charles L Bowden, MD, University of Texas
  • Principal Investigator: Vivek Singh, MD, University of Texas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Actual)

May 16, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0340013419

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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