Efficacy and Safety of Duloxetine Among Individuals With Depressive Disorder in a 12 Weeks Trial

The aim of this study was to investigate the effects of duloxetine on improvement of brain cortical activity in patients suffering from major depressive disorder using near infrared spectroscopy.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

HAMD-17 more than 12 points
Participants could understand this study and sign permit
Participants could receive NIRS measurements
Participants could comply with the protocol of the study

Exclusion criteria

alcohol or substance abuse within 3 months of the study
ever participate other clinical study related to duloxetine
previous poor treatment effects of duloxetine
concomitant use of MAOi within 14 days
concomitant use of Linezolid
with uncontrolled glaucoma

Treatment and study plan

Duloxetine

Drug

duloxetine 30 to 60 mg tablets by mouth, QD to BID per day,

Primary outcomes

Change in Depression severity

Time frame: 0-2-4-8-12 weeks

Hamilton Rating Scale for Depression

Secondary outcomes

Change in Brain cortical activity

Time frame: 0-2-4-8-12 weeks

Using Near Infrared Spectroscopy

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2017
First posted: Apr 20, 2017
Registry last updated: Apr 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed