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

• Sponsor: Taichung Veterans General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03121573
• Collaborator: (none)
• Enrollment: 30
• Arm: 1
• Actual Duration (Months): 25.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: Duloxetine	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Efficacy and Safety of Duloxetine Among Individuals With Depressive Disorder in a 12 Weeks Trial
• Actual Study Start Date: Dec 15, 2014
• Actual Primary Completion Date: Sep 26, 2016
• Actual Study Completion Date: Jan 17, 2017

Arms and Interventions

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,

Outcome Measures

Primary Outcome Measures

1. Change in Depression severity [0-2-4-8-12 weeks]

   Hamilton Rating Scale for Depression

Secondary Outcome Measures

1. Change in Brain cortical activity [0-2-4-8-12 weeks]

   Using Near Infrared Spectroscopy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Taichung Veterans General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Taichung Veterans General Hospital
• ClinicalTrials.gov Identifier: NCT03121573
• Other Study ID Numbers: SF14216
• First Posted: Apr 20, 2017
• Last Update Posted: Apr 20, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Taichung Veterans General Hospital: near infrared spectroscopy, NIRS, duloxetine
• Additional relevant MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Duloxetine Hydrochloride

Study Results

No Results Posted as of Apr 20, 2017