search
Back to results

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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Duloxetine
Sponsored by
Taichung Veterans General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Major Depressive Disorder focused on measuring near infrared spectroscopy, NIRS, duloxetine

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    intervention

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Change in Depression severity
    Hamilton Rating Scale for Depression

    Secondary Outcome Measures

    Change in Brain cortical activity
    Using Near Infrared Spectroscopy

    Full Information

    First Posted
    April 13, 2017
    Last Updated
    April 18, 2017
    Sponsor
    Taichung Veterans General Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03121573
    Brief Title
    Efficacy and Safety of Duloxetine Among Individuals With Depressive Disorder in a 12 Weeks Trial
    Official Title
    Efficacy and Safety of Duloxetine Among Individuals With Depressive Disorder in a 12 Weeks Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 15, 2014 (Actual)
    Primary Completion Date
    September 26, 2016 (Actual)
    Study Completion Date
    January 17, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taichung Veterans General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Major Depressive Disorder
    Keywords
    near infrared spectroscopy, NIRS, duloxetine

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention
    Arm Type
    Other
    Arm Description
    medication: duloxetine 30 to 60 mg tablets by mouth, QD to BID.
    Intervention Type
    Drug
    Intervention Name(s)
    Duloxetine
    Intervention Description
    duloxetine 30 to 60 mg tablets by mouth, QD to BID per day,
    Primary Outcome Measure Information:
    Title
    Change in Depression severity
    Description
    Hamilton Rating Scale for Depression
    Time Frame
    0-2-4-8-12 weeks
    Secondary Outcome Measure Information:
    Title
    Change in Brain cortical activity
    Description
    Using Near Infrared Spectroscopy
    Time Frame
    0-2-4-8-12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    no plan

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs