Clincosm LogoSign in Get a demo

Aripiprazole for the Augmentation of Antidepressant Therapy

Sponsor
Taiwan Otsuka Pharm. Co., Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT01429831
Collaborator
(none)
300
Enrollment
1
Location
1
Arm
20
Duration (Months)
15
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
300 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Sep 1, 2011
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
May 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. 17-Item Hamilton Depression Rating Scale (HAM-D17) score [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 Outcome Measures

  1. Clinical Global Impression of Severity (CGI-S) score [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 [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 [Week 6]

    Change from baseline in WHOQOL-BREF score at Week 6

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taiwan Otsuka Pharm. Co., Ltd
ClinicalTrials.gov Identifier:
NCT01429831
Other Study ID Numbers:
  • 031-TWB-1101i
First Posted:
Sep 7, 2011
Last Update Posted:
May 21, 2014
Last Verified:
May 1, 2014
Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Aripiprazole

Study Results

No Results Posted as of May 21, 2014