Aripiprazole for the Augmentation of Antidepressant Therapy

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiwan Otsuka Pharm. Co., Ltd
• Treatments: Antidepressive Agents; Aripiprazole

Criteria

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