Aripiprazole for the Augmentation of Antidepressant Therapy

NCT01429831 | Completed Phase 4

• 1 other identifier: 031-TWB-1101i
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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: 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

  Week 1, 2, 4 and 6

Secondary Outcomes (3)

• Clinical Global Impression of Severity (CGI-S) score

  Week 1, 2, 4 and 6

• Sheehan Disability Scale (SDS) total score

  Week 1, 2, 4 and 6

• World Health Organization Quality of Life (WHOQOL-BREF) score

  Week 6

Study Arms (1)

Aripiprazole

EXPERIMENTAL

Drug: Aripiprazole

Interventions

Aripiprazole DRUG

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.

Aripiprazole

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taiwan Otsuka Pharm. Co., Ltd: lead

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Te-Jen Lai, MD

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2011
• First Posted: September 7, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 21, 2014

Record last verified: 2014-05

Locations

TW (1)