Status:
COMPLETED
Aripiprazole for the Augmentation of Antidepressant Therapy
Lead Sponsor:
Taiwan Otsuka Pharm. Co., Ltd
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
20-65 years
Phase:
PHASE4
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 clini...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01429831
Start Date
September 1 2011
End Date
May 1 2013
Last Update
May 21 2014
Active Locations (1)
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1
Chung Shan Medical University Hospital
Taichung, Taiwan