Analisis of Facors Involved in Antidepressant Treatment Response of Major Depressive Disorder (AFADTRMDD)

This study has been completed.
Information provided by (Responsible Party):
Gentaro Nishioka, Showa University Identifier:
First received: October 17, 2011
Last updated: October 27, 2011
Last verified: October 2011
The purpose of this study is to predict and visualize sertraline treatment response in major depressive disorder with clinical symptoms, demographic and stress state, personality, eight genetic polymorphisms at baseline.

Condition Intervention
Major Depressive Disorder
Drug: Sertraline

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment Response Study of Sertraline to Treat Japanese Major Depressive Disorder

Resource links provided by NLM:

Further study details as provided by Showa University:

Primary Outcome Measures:
  • Hamilton Rating Scale for Depression [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 96
Study Start Date: June 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sertraline, Treatment response
dosage, frequency and duration
Drug: Sertraline
dosage,frequency and duration
Other Name: J Zoloft®

Detailed Description:
While only about 50% of patients respond to first treatment in major depressive disorder, 30-40% did not remit after continuous 1 year treatment. However, patients must remain on their prescribed medications for at least 4 weeks without knowing whether the particular antidepressant will be effective. Studies have suggested a number of predictors of treatment response, but varying degrees of success and nearly all with poor prognostic sensitivity and specificity. The investigators investigated clinical symptoms, demographic and stress state, personality and genetic polymorphisms in patients of major depressive disorder treated with sertraline and performed multivariate analysis to extract the predicting factors. Moreover, the investigators tried to visualize weight of variables and pathway one another.

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • clinical diagnosis of Major Depressive Disorder
  • Must be able to swallow tablets

Exclusion Criteria:

  • pregnant
  • breastfeeding
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Please refer to this study by its identifier: NCT01454635

Showa University Northern Yokohama Hospital
Yokohama, Kanagawa, Japan, 224-8503
Sponsors and Collaborators
Showa University
Study Director: Yuji Kiuchi, Professor Showa University
  More Information

Responsible Party: Gentaro Nishioka, Tokyo Metropolitan Police Hospital, Department of Psychiatry, Principal Investigator, Showa University Identifier: NCT01454635     History of Changes
Other Study ID Numbers: SU-GEC-84 
Study First Received: October 17, 2011
Last Updated: October 27, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Showa University:
treatment response
selective serotonin reuptake inhibitor

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses processed this record on May 02, 2016