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NCT03121573 Clinical Trial

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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03121573
Other study ID # SF14216
Secondary ID
Status Completed
Phase N/A
First received April 13, 2017
Last updated April 18, 2017
Start date December 15, 2014
Est. completion date January 17, 2017

Study information
Verified date April 2017
Source Taichung Veterans General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date January 17, 2017
Est. primary completion date September 26, 2016
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Taichung Veterans General Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Depression severity Hamilton Rating Scale for Depression 0-2-4-8-12 weeks
Secondary Change in Brain cortical activity Using Near Infrared Spectroscopy 0-2-4-8-12 weeks
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