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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gentaro Nishioka, Showa University
ClinicalTrials.gov Identifier:
NCT01454635
First received: October 17, 2011
Last updated: October 27, 2011
Last verified: October 2011
History of Changes
  Purpose

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:

U.S. FDA Resources

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.

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant
  • breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01454635

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

No publications provided

Responsible Party: Gentaro Nishioka, Tokyo Metropolitan Police Hospital, Department of Psychiatry, Principal Investigator, Showa University
ClinicalTrials.gov 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:
depression
treatment response
selective serotonin reuptake inhibitor

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

ClinicalTrials.gov processed this record on May 19, 2013