NCT03121573

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable major-depressive-disorder

Timeline
Completed

Started Dec 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2017

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

1.8 years

First QC Date

April 13, 2017

Last Update Submit

April 18, 2017

Conditions

Major Depressive Disorder

Keywords

near infrared spectroscopy, NIRS, duloxetine

Outcome Measures

Primary Outcomes (1)

  • Change in Depression severity

    Hamilton Rating Scale for Depression

    0-2-4-8-12 weeks

Secondary Outcomes (1)

  • Change in Brain cortical activity

    0-2-4-8-12 weeks

Study Arms (1)

intervention

OTHER

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

Drug: Duloxetine

Interventions

DuloxetineDRUG

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

intervention

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2017

First Posted

April 20, 2017

Study Start

December 15, 2014

Primary Completion

September 26, 2016

Study Completion

January 17, 2017

Last Updated

April 20, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

no plan