We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01454635
First Posted: October 19, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gentaro Nishioka, Showa University
  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: None (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 Gentaro Nishioka, Showa University:

Primary Outcome Measures:
  • Hamilton Rating Scale for Depression [ Time Frame: 8 weeks ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: October 17, 2011
First Posted: October 19, 2011
Last Update Posted: October 12, 2017
Last Verified: October 2011

Keywords provided by Gentaro Nishioka, Showa University:
depression
treatment response
selective serotonin reuptake inhibitor

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Sertraline
Serotonin Uptake Inhibitors
Antidepressive Agents
Psychotropic Drugs
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs