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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03121573

Enrollment

Registered

2017-04-20

Start date

2014-12-15

Completion date

2017-01-17

Last updated

2017-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

near infrared spectroscopy, NIRS, duloxetine

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.

Interventions

DRUGDuloxetine

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

Study design

Intervention model

SEQUENTIAL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Depression severity	0-2-4-8-12 weeks	Hamilton Rating Scale for Depression

Secondary

Measure	Time frame	Description
Change in Brain cortical activity	0-2-4-8-12 weeks	Using Near Infrared Spectroscopy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026