Back to results

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

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

Sertraline

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring depression, treatment response, selective serotonin reuptake inhibitor

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

pregnant
breastfeeding

Sites / Locations

Showa University Northern Yokohama Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Sertraline, Treatment response

Arm Description

dosage, frequency and duration

Outcomes

Primary Outcome Measures

Hamilton Rating Scale for Depression

Secondary Outcome Measures

Full Information

NCT ID

NCT01454635

First Posted

October 17, 2011

Last Updated

October 27, 2011

Sponsor

Showa University

1. Study Identification

Unique Protocol Identification Number

NCT01454635

Brief Title

Analisis of Facors Involved in Antidepressant Treatment Response of Major Depressive Disorder

Acronym

AFADTRMDD

Official Title

Treatment Response Study of Sertraline to Treat Japanese Major Depressive Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Showa University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

depression, treatment response, selective serotonin reuptake inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sertraline, Treatment response

Arm Type

Other

Arm Description

dosage, frequency and duration

Intervention Type

Drug

Intervention Name(s)

Sertraline

Other Intervention Name(s)

J Zoloft®

Intervention Description

dosage,frequency and duration

Primary Outcome Measure Information:

Title

Hamilton Rating Scale for Depression

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: clinical diagnosis of Major Depressive Disorder Must be able to swallow tablets Exclusion Criteria: pregnant breastfeeding

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yuji Kiuchi, Professor

Organizational Affiliation

Showa University

Official's Role

Study Director

Facility Information:

Facility Name

Showa University Northern Yokohama Hospital

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

224-8503

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

Analisis of Facors Involved in Antidepressant Treatment Response of Major Depressive Disorder

We'll reach out to this number within 24 hrs