Aripiprazole for the Augmentation of Antidepressant Therapy

May 19, 2014 updated by: Taiwan Otsuka Pharm. Co., Ltd

Aripiprazole for the Augmentation of Antidepressant Therapy: An Observational, Outpatients Study in Inadequate Responders Diagnosed With Major Depressive Disorder

The study aims to evaluate effectiveness and tolerability of aripiprazole augmentation in outpatients with major depressive disorder who have had inadequate response to antidepressants in Taiwan clinical practice.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

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

      • Taichung, Taiwan
        • Chung Shan Medical University Hospital

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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Outpatients, either gender, 20-65 years of age
  • Patients diagnosed with major depressive disorder as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), who fulfill both the following criteria:

    • Having at least one and no more than three inadequate responses of antidepressants
    • HAM-D17 score ≥ 14
  • Willing and able to comply with the study procedure and sign a written informed consent

Exclusion Criteria:

  • Females who are pregnant/lactating or planning to be pregnant
  • Presence of personality disorder cluster B (dramatic, emotional or erratic disorders) or any psychotic symptomatology in the current depressive episode based on Investigators judgment
  • History of organic mental disorder within 1 year prior to the screening visit
  • Acute risk of suicide attempts within 3 months prior to the initiation of study treatment (HAM D-17 score item 3 ≥ 3)
  • Electroconvulsive therapy (ECT) for current episode
  • Past exposure to aripiprazole treatment or any investigational product (including drug and invasive medical device) within 4 weeks prior to the initiation of study treatment
  • History of substance / alcohol abuse within 1 year prior to the screening visit
  • Patient with any medical or psychotic feature, including the presence of significant abnormal laboratory values, which is considered not suitable for this study by Investigator

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
starting aripiprazole dose from 2-5mg/day, dose adjustment by every week, and maximum dose can up to 15mg/day. The duration is 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
17-Item Hamilton Depression Rating Scale (HAM-D17) score
Time Frame: Week 1, 2, 4 and 6

Primary effectiveness endpoint:

- Change from baseline in HAM-D17 score at Week 6

Secondary effectiveness endpoints:

  1. Change from baseline in HAM-D17 score at Week 1, 2 and 4
  2. Response rate at Week 1, 2, 4 and 6

    - Response rate: decrease in HAM-D17 total score of at least 50%

  3. Remission rate at Week 1, 2, 4 and 6 - Remission rate: HAMD-17 score ≤ 7
Week 1, 2, 4 and 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression of Severity (CGI-S) score
Time Frame: Week 1, 2, 4 and 6
  1. Change from baseline in CGI-S score at Week 1, 2, 4 and 6
  2. CGI-I score at Week 1, 2, 4 and 6
Week 1, 2, 4 and 6
Sheehan Disability Scale (SDS) total score
Time Frame: Week 1, 2, 4 and 6
Change from baseline in SDS total score at Week 1, 2, 4 and 6
Week 1, 2, 4 and 6
World Health Organization Quality of Life (WHOQOL-BREF) score
Time Frame: Week 6
Change from baseline in WHOQOL-BREF score at Week 6
Week 6

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Te-Jen Lai, MD, Chung Shan Medical University

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, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

September 1, 2011

First Submitted That Met QC Criteria

September 6, 2011

First Posted (Estimate)

September 7, 2011

Study Record Updates

Last Update Posted (Estimate)

May 21, 2014

Last Update Submitted That Met QC Criteria

May 19, 2014

Last Verified

May 1, 2014

More Information

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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