Aripiprazole for the Augmentation of Antidepressant Therapy

Phase 4

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Aripiprazole

• Registration Number: NCT01429831
• Lead Sponsor: Taiwan Otsuka Pharm. Co., Ltd

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 clinical practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-01
• Study First Submitted QC: 2011-09-06
• Study First Posted: 2011-09-07
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-19
• Last Update Posted: 2014-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aripiprazole	Aripiprazole	-

Primary Outcome Measures

Name	Time	Method
17-Item Hamilton Depression Rating Scale (HAM-D17) score	Week 1, 2, 4 and 6	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

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression of Severity (CGI-S) score	Week 1, 2, 4 and 6	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
Sheehan Disability Scale (SDS) total score	Week 1, 2, 4 and 6	Change from baseline in SDS total score at Week 1, 2, 4 and 6
World Health Organization Quality of Life (WHOQOL-BREF) score	Week 6	Change from baseline in WHOQOL-BREF score at Week 6

Trial Locations

Locations (1)

Chung Shan Medical University Hospital; 🇨🇳 Taichung, Taiwan