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Completed

NCT Number: NCT01429831

Aripiprazole for the Augmentation of Antidepressant Therapy

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chung Shan Medical University Hospital

Taichung, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aripiprazole

Drug

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 outcomes

  1. 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:

    • 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 outcomes

  1. Clinical Global Impression of Severity (CGI-S) score

    Time frame: Week 1, 2, 4 and 6

    • Change from baseline in CGI-S score at Week 1, 2, 4 and 6
    • CGI-I score at Week 1, 2, 4 and 6

  2. 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

  3. World Health Organization Quality of Life (WHOQOL-BREF) score

    Time frame: Week 6

    Change from baseline in WHOQOL-BREF score at Week 6

Sponsors and collaborators

Lead sponsor

Taiwan Otsuka Pharm. Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 7, 2011
Registry last updated
May 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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