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

April 18, 2017 updated by: Taichung Veterans General Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: intervention
medication: duloxetine 30 to 60 mg tablets by mouth, QD to BID.
Drug: Duloxetine
duloxetine 30 to 60 mg tablets by mouth, QD to BID per day,

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Veterans General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2014

Primary Completion (Actual)

September 26, 2016

Study Completion (Actual)

January 17, 2017

Study Registration Dates

First Submitted

April 13, 2017

First Submitted That Met QC Criteria

April 18, 2017

First Posted (Actual)

April 20, 2017

Study Record Updates

Last Update Posted (Actual)

April 20, 2017

Last Update Submitted That Met QC Criteria

April 18, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SF14216

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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