Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

September 1, 2011
May 19, 2014
September 2011
May 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01429831 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Aripiprazole for the Augmentation of Antidepressant Therapy
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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Major Depressive Disorder
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.
Experimental: Aripiprazole
Intervention: Drug: Aripiprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01429831
031-TWB-1101i
Not Provided
Taiwan Otsuka Pharm. Co., Ltd
Taiwan Otsuka Pharm. Co., Ltd
Not Provided
Principal Investigator: Te-Jen Lai, MD Chung Shan Medical University Hospital
Taiwan Otsuka Pharm. Co., Ltd
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP