Aripiprazole for the Augmentation of Antidepressant Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taiwan Otsuka Pharm. Co., Ltd
ClinicalTrials.gov Identifier:
NCT01429831
First received: September 1, 2011
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: Aripiprazole
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aripiprazole for the Augmentation of Antidepressant Therapy: An Observational, Outpatients Study in Inadequate Responders Diagnosed With Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Taiwan Otsuka Pharm. Co., Ltd:

Primary Outcome Measures:
  • 17-Item Hamilton Depression Rating Scale (HAM-D17) score [ Time Frame: Week 1, 2, 4 and 6 ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Clinical Global Impression of Severity (CGI-S) score [ Time Frame: Week 1, 2, 4 and 6 ] [ Designated as safety issue: No ]
    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

  • Sheehan Disability Scale (SDS) total score [ Time Frame: Week 1, 2, 4 and 6 ] [ Designated as safety issue: No ]
    Change from baseline in SDS total score at Week 1, 2, 4 and 6

  • World Health Organization Quality of Life (WHOQOL-BREF) score [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    Change from baseline in WHOQOL-BREF score at Week 6


Enrollment: 300
Study Start Date: September 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aripiprazole Drug: 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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429831

Locations
Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan
Sponsors and Collaborators
Taiwan Otsuka Pharm. Co., Ltd
Investigators
Principal Investigator: Te-Jen Lai, MD Chung Shan Medical University Hospital
  More Information

No publications provided

Responsible Party: Taiwan Otsuka Pharm. Co., Ltd
ClinicalTrials.gov Identifier: NCT01429831     History of Changes
Other Study ID Numbers: 031-TWB-1101i
Study First Received: September 1, 2011
Last Updated: May 19, 2014
Health Authority: Taiwan: Department of Health (DOH)

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Aripiprazole
Antidepressive Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 18, 2014