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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aripiprazole | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Week 1, 2, 4 and 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression of Severity (CGI-S) score |
| Week 1, 2, 4 and 6 |
| Sheehan Disability Scale (SDS) total score |
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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:
Willing and able to comply with the study procedure and sign a written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Te-Jen Lai, MD | Chung Shan Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung Shan Medical University Hospital | Taichung | Taiwan |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
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Change from baseline in SDS total score at Week 1, 2, 4 and 6
| 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 | Week 6 |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |