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Aripiprazole for the Augmentation of Antidepressant Therapy

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
Taiwan Otsuka Pharm. Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chung Shan Medical University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aripiprazole

Arm Description

Outcomes

Primary Outcome Measures

17-Item Hamilton Depression Rating Scale (HAM-D17) score
Primary effectiveness endpoint: - Change from baseline in HAM-D17 score at Week 6 Secondary effectiveness endpoints: Change from baseline in HAM-D17 score at Week 1, 2 and 4 Response rate at Week 1, 2, 4 and 6 - Response rate: decrease in HAM-D17 total score of at least 50% Remission rate at Week 1, 2, 4 and 6 - Remission rate: HAMD-17 score ≤ 7

Secondary Outcome Measures

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

Full Information

First Posted
September 1, 2011
Last Updated
May 19, 2014
Sponsor
Taiwan Otsuka Pharm. Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01429831
Brief Title
Aripiprazole for the Augmentation of Antidepressant Therapy
Official Title
Aripiprazole for the Augmentation of Antidepressant Therapy: An Observational, Outpatients Study in Inadequate Responders Diagnosed With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiwan Otsuka Pharm. Co., Ltd

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Aripiprazole
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Intervention Description
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.
Primary Outcome Measure Information:
Title
17-Item Hamilton Depression Rating Scale (HAM-D17) score
Description
Primary effectiveness endpoint: - Change from baseline in HAM-D17 score at Week 6 Secondary effectiveness endpoints: Change from baseline in HAM-D17 score at Week 1, 2 and 4 Response rate at Week 1, 2, 4 and 6 - Response rate: decrease in HAM-D17 total score of at least 50% Remission rate at Week 1, 2, 4 and 6 - Remission rate: HAMD-17 score ≤ 7
Time Frame
Week 1, 2, 4 and 6
Secondary Outcome Measure Information:
Title
Clinical Global Impression of Severity (CGI-S) score
Description
Change from baseline in CGI-S score at Week 1, 2, 4 and 6 CGI-I score at Week 1, 2, 4 and 6
Time Frame
Week 1, 2, 4 and 6
Title
Sheehan Disability Scale (SDS) total score
Description
Change from baseline in SDS total score at Week 1, 2, 4 and 6
Time Frame
Week 1, 2, 4 and 6
Title
World Health Organization Quality of Life (WHOQOL-BREF) score
Description
Change from baseline in WHOQOL-BREF score at Week 6
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Te-Jen Lai, MD
Organizational Affiliation
Chung Shan Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung Shan Medical University Hospital
City
Taichung
Country
Taiwan

12. IPD Sharing Statement

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Aripiprazole for the Augmentation of Antidepressant Therapy

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