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

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Duloxetine

• Registration Number: NCT03121573
• Lead Sponsor: Taichung Veterans General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-15
• Primary Completion: 2016-09-26
• Study Completion: 2017-01-17
• Status Verified: 2017-04
• Study First Submitted: 2017-04-13
• Study First Submitted QC: 2017-04-18
• Last Update Submitted: 2017-04-18
• Study First Posted: 2017-04-20
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
intervention	Duloxetine	medication: duloxetine 30 to 60 mg tablets by mouth, QD to BID.

Primary Outcome Measures

Name	Time	Method
Change in Depression severity	0-2-4-8-12 weeks	Hamilton Rating Scale for Depression

Secondary Outcome Measures

Name	Time	Method
Change in Brain cortical activity	0-2-4-8-12 weeks	Using Near Infrared Spectroscopy