Aripiprazole for the Augmentation of Antidepressant Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Aripiprazole for the Augmentation of Antidepressant Therapy: An Observational, Outpatients Study in Inadequate Responders Diagnosed With Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Aripiprazole


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aripiprazole<br> | Drug: Aripiprazole<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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: 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 | Week 1, 2, 4 and 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression of Severity (CGI-S) score | Change from baseline in CGI-S score at Week 1, 2, 4 and 6 CGI-I score at Week 1, 2, 4 and 6 | 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 | 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 |