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

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. Identifier: NCT01454635
Recruitment Status : Completed
First Posted : October 19, 2011
Last Update Posted : October 31, 2011
Information provided by (Responsible Party):
Gentaro Nishioka, Showa University

Brief Summary:
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 or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Sertraline Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
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
Study Start Date : June 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Sertraline, Treatment response
dosage, frequency and duration
Drug: Sertraline
dosage,frequency and duration
Other Name: J Zoloft®

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

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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant
  • breastfeeding

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 identifier (NCT number): NCT01454635

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

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
First Posted: October 19, 2011    Key Record Dates
Last Update Posted: October 31, 2011
Last Verified: October 2011

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

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
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