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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 26, 2016

Interventions

  • Drug: Duloxetine
    • duloxetine 30 to 60 mg tablets by mouth, QD to BID per day,

Arms, Groups and Cohorts

  • Other: intervention
    • medication: duloxetine 30 to 60 mg tablets by mouth, QD to BID.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Depression severity
    • Time Frame: 0-2-4-8-12 weeks
    • Hamilton Rating Scale for Depression

Secondary Measures

  • Change in Brain cortical activity
    • Time Frame: 0-2-4-8-12 weeks
    • Using Near Infrared Spectroscopy

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Taichung Veterans General Hospital
  • Provider of Information About this Clinical Study
    • Sponsor

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