Aripiprazole for the Augmentation of Antidepressant Therapy

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01429831
• Other study ID #: 031-TWB-1101i
• Status: Completed
• Phase: Phase 4
• First received: September 1, 2011
• Last updated: May 19, 2014
• Start date: September 2011
• Est. completion date: May 2013

Study information

• Verified date: May 2014
• Source: Taiwan Otsuka Pharm. Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health (DOH)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Aripiprazole
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.

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taiwan Otsuka Pharm. Co., Ltd

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	World Health Organization Quality of Life (WHOQOL-BREF) score	Change from baseline in WHOQOL-BREF score at Week 6	Week 6	No