Efficacy and Safety of Duloxetine Among Individuals With... | NCT03121573

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

NCT03121573

Sponsor

Taichung Veterans General Hospital

Status

Completed

Last Update Posted

Apr 20, 2017Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Major Depressive Disorder

Interventions

Duloxetine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2014Actual

Primary Completion Date

Sep 26, 2016Actual

Completion Date

Jan 17, 2017Actual

First Submitted Date

Apr 13, 2017

First Submission Date that Met QC Criteria

Apr 18, 2017

First Posted Date

Apr 20, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2017

Last Update Posted Date

Apr 20, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention	Other	medication: duloxetine 30 to 60 mg tablets by mouth, QD to BID.	Drug: Duloxetine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Duloxetine	Drug	duloxetine 30 to 60 mg tablets by mouth, QD to BID per day,	intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

no plan

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068736	Duloxetine Hydrochloride

Ancestor Terms

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided