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Trial record 83 of 408 for:    ARIPIPRAZOLE

Aripiprazole for the Augmentation of Antidepressant Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01429831
Recruitment Status : Completed
First Posted : September 7, 2011
Last Update Posted : May 21, 2014
Sponsor:
Information provided by (Responsible Party):
Taiwan Otsuka Pharm. Co., Ltd

Tracking Information
First Submitted Date  ICMJE September 1, 2011
First Posted Date  ICMJE September 7, 2011
Last Update Posted Date May 21, 2014
Study Start Date  ICMJE September 2011
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01429831 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2011)
  • 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
  • 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
  • World Health Organization Quality of Life (WHOQOL-BREF) score [ Time Frame: Week 6 ]
    Change from baseline in WHOQOL-BREF score at Week 6
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2011)
  • 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
  • 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
  • WHOQOL-BREF score [ Time Frame: Week 6 ]
    Change from baseline in WHOQOL-BREF score at Week 6
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aripiprazole for the Augmentation of Antidepressant Therapy
Official Title  ICMJE Aripiprazole for the Augmentation of Antidepressant Therapy: An Observational, Outpatients Study in Inadequate Responders Diagnosed With Major Depressive Disorder
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Aripiprazole
Intervention: Drug: Aripiprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 6, 2011)
300
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01429831
Other Study ID Numbers  ICMJE 031-TWB-1101i
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Taiwan Otsuka Pharm. Co., Ltd
Study Sponsor  ICMJE Taiwan Otsuka Pharm. Co., Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Te-Jen Lai, MD Chung Shan Medical University
PRS Account Taiwan Otsuka Pharm. Co., Ltd
Verification Date May 2014

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