- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01429831
Aripiprazole for the Augmentation of Antidepressant Therapy
May 19, 2014 updated by: Taiwan Otsuka Pharm. Co., Ltd
Aripiprazole for the Augmentation of Antidepressant Therapy: An Observational, Outpatients Study in Inadequate Responders Diagnosed With Major Depressive Disorder
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taichung, Taiwan
- Chung Shan Medical University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
17-Item Hamilton Depression Rating Scale (HAM-D17) score
Time Frame: Week 1, 2, 4 and 6
|
Primary effectiveness endpoint: - Change from baseline in HAM-D17 score at Week 6 Secondary effectiveness endpoints:
|
Week 1, 2, 4 and 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Global Impression of Severity (CGI-S) score
Time Frame: Week 1, 2, 4 and 6
|
|
Week 1, 2, 4 and 6
|
Sheehan Disability Scale (SDS) total score
Time Frame: Week 1, 2, 4 and 6
|
Change from baseline in SDS total score at Week 1, 2, 4 and 6
|
Week 1, 2, 4 and 6
|
World Health Organization Quality of Life (WHOQOL-BREF) score
Time Frame: Week 6
|
Change from baseline in WHOQOL-BREF score at Week 6
|
Week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Te-Jen Lai, MD, Chung Shan Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
September 1, 2011
First Submitted That Met QC Criteria
September 6, 2011
First Posted (Estimate)
September 7, 2011
Study Record Updates
Last Update Posted (Estimate)
May 21, 2014
Last Update Submitted That Met QC Criteria
May 19, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agonists
- Dopamine Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Aripiprazole
Other Study ID Numbers
- 031-TWB-1101i
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Major Depressive Disorder
-
Shalvata Mental Health CenterUnknownMAjor Depressive DisorderIsrael
-
York UniversityCentre for Addiction and Mental HealthSuspendedDisorder, Major DepressiveCanada
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDDIndia
-
Gangnam Severance HospitalCompletedMajor Depressive Disorder(MDD)Korea, Republic of
-
University College, LondonCompletedUnipolar Major Depressive DisorderUnited Kingdom
-
Fundació Institut de Recerca de l'Hospital de la...Fondo de Investigacion SanitariaUnknown
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDD)India
-
Repurposed Therapeutics, Inc.Unknown
-
GlaxoSmithKlineCompletedMajor Depressive Disorder (MDD)United States
-
AccexibleRecruitingMajor Depressive Disorder (MDD)Spain
Clinical Trials on Aripiprazole
-
National Institute on Alcohol Abuse and Alcoholism...Brown UniversityCompleted
-
Otsuka Beijing Research InstituteCompleted
-
H. Lundbeck A/SOtsuka Pharmaceutical Co., Ltd.CompletedSchizophreniaUnited States
-
University of California, Los AngelesAlkermes, Inc.TerminatedSchizophrenia | Schizophreniform Disorder | Schizoaffective Disorder, Depressive TypeUnited States
-
Otsuka Pharmaceutical Co., Ltd.CompletedMajor Depressive DisorderJapan
-
Veterans Medical Research FoundationBristol-Myers SquibbCompleted
-
Otsuka Pharmaceutical Co., Ltd.CompletedSchizophreniaJapan
-
Otsuka Pharmaceutical Development & Commercialization...CompletedSchizophreniaKorea, Republic of, United States, Estonia, Italy, Hungary, Bulgaria, Croatia, France, Poland, Thailand, Puerto Rico, Chile, South Africa, Austria, Belgium
-
Alkermes, Inc.CompletedSchizophreniaUnited States
-
Alkermes, Inc.CompletedSchizophreniaUnited States