NCT01454635

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable major-depressive-disorder

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2011

Completed
Last Updated

October 31, 2011

Status Verified

October 1, 2011

Enrollment Period

1.7 years

First QC Date

October 17, 2011

Last Update Submit

October 27, 2011

Conditions

Major Depressive Disorder

Keywords

depressiontreatment responseselective serotonin reuptake inhibitor

Outcome Measures

Primary Outcomes (1)

  • Hamilton Rating Scale for Depression

    8 weeks

Study Arms (1)

Sertraline, Treatment response

OTHER

dosage, frequency and duration

Drug: Sertraline

Interventions

SertralineDRUG

dosage,frequency and duration

Also known as: J Zoloft®
Sertraline, Treatment response

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • pregnant
  • breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Showa University Northern Yokohama Hospital

Yokohama, Kanagawa, 224-8503, Japan

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Yuji Kiuchi, Professor

    Showa University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Tokyo Metropolitan Police Hospital, Department of Psychiatry, Principal Investigator

Study Record Dates

First Submitted

October 17, 2011

First Posted

October 19, 2011

Study Start

June 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

October 31, 2011

Record last verified: 2011-10

Locations

JP(1)