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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
300
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.
Chung Shan Medical University Hospital
Taichung, Taiwan
17-Item Hamilton Depression Rating Scale (HAM-D17) score
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
Time frame: Week 1, 2, 4 and 6
Clinical Global Impression of Severity (CGI-S) score
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
Time frame: Week 1, 2, 4 and 6
Sheehan Disability Scale (SDS) total score
Change from baseline in SDS total score at Week 1, 2, 4 and 6
Time frame: Week 1, 2, 4 and 6
World Health Organization Quality of Life (WHOQOL-BREF) score
Change from baseline in WHOQOL-BREF score at Week 6
Time frame: Week 6
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