Brief Summary

The purpose of this study is to assess nausea severity in response to four different drug dosing strategies of Duloxetine (30 mg with food, 60 mg with food, 30 mg without food, and 60 mg without food) in Korean patients with major depressive disorder (MDD).

Trial Health

On Track

Trial Health Score

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

Enrollment

249

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Aug 2009

Geographic Reach

1 country

7 active sites

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

1.7 years study duration

Study Start

First participant enrolled

August 1, 2009

Completed

16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2009

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed

1 year until next milestone

Results Posted

Study results publicly available

April 17, 2012

Completed

Last Updated

December 31, 2014

Status Verified

December 1, 2014

Enrollment Period

1.5 years

First QC Date

August 17, 2009

Results QC Date

January 17, 2012

Last Update Submit

December 8, 2014

Conditions

Major Depressive Disorder (MDD)

Outcome Measures

Primary Outcomes (1)

Mean Maximum Nausea Severity, Association for Methodology and Documentation in Psychiatry (AMDP-5) Adverse Event (AE) Scale Item 112 (Nausea)
AMDP-5 AE scale Item 112 (nausea) measured nausea severity during treatment (Week 0-8). The scores ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe.
1 week and 8 weeks

Secondary Outcomes (15)

Mean Change From Baseline to 8-Week Endpoint in Association for Methodology and Documentation in Psychiatry (AMDP-5) Adverse Event (AE) Scale Item 112 (Nausea)
Baseline, 8 weeks
Mean Change From Baseline to 1-Week and 8-Week Endpoints in Association for Methodology and Documentation in Psychiatry (AMDP-5) Measure: Gastric Events Score
Baseline, 1 week and 8 weeks
Mean Change From Baseline to 1-Week and 8-Week Endpoints in Association for Methodology and Documentation in Psychiatry (AMDP-5) Measure: Common Adverse Events (AEs) Score
Baseline, 1 week, 8 weeks
Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score
Baseline, 1 week, 8 weeks
Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale
Baseline, 1 week, 8 weeks
+10 more secondary outcomes

Study Arms (4)

Duloxetine 60 mg with food

EXPERIMENTAL

Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks

Drug: Duloxetine hydrochloride

Duloxetine 60 mg without food

EXPERIMENTAL

Duloxetine 60 mg capsule po QD without food for 8 weeks

Drug: Duloxetine hydrochloride

Duloxetine 30 mg with food

EXPERIMENTAL

Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks

Drug: Duloxetine hydrochloride

Duloxetine 30 mg without food

EXPERIMENTAL

Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks

Drug: Duloxetine hydrochloride

Interventions

Duloxetine hydrochlorideDRUG

po, QD

Also known as: Cymbalta, LY248686

Duloxetine 30 mg with foodDuloxetine 30 mg without foodDuloxetine 60 mg with foodDuloxetine 60 mg without food

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

For females of child-bearing potential test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.
item Hamilton Depression Rating Scale (HAMD-17) total score \>15 at Screening and Randomization
Have signed the informed consent document (ICD)
Have a level of understanding sufficient to provide informed consent and to communicate with the investigators and site personnel
Are judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures required by the protocol
Patients must meet Diagnostic and Statistical Manual of Mental Disorders-fourth edition-text revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD). The Mini International Neuropsychiatric Interview (MINI) will be used to establish the diagnosis and exclude other psychiatric illnesses.

You may not qualify if:

Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
Have any current primary Axis I disorder other than MDD
Have any previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders
Lack of response of the current episode of major depression to two or more adequate courses of antidepressant therapy at clinically appropriate dose for a minimum of 4 weeks or, in the judgment of the investigator, the patient meets criteria for treatment-resistant depression
Have a history of a lack of response, at any time, to an adequate trial of duloxetine (defined as treatment with at least 60 mg/day of duloxetine for a minimum of 4 weeks)
Presence of an Axis II disorder that, in the judgment of the investigator, would interfere with study compliance
DSM-IV-TR-defined history of substance abuse or dependence within the past 6 months, excluding nicotine and caffeine
Patients judged to be at serious suicidal risk in the opinion of the investigator and/or score ≥3 on Item 3 (suicide) of the HAMD-17
Serious medical illness or clinically significant laboratory abnormalities that, in the judgment of the investigator, are likely to require intervention/hospitalization/excluded medication during the course of the study Note: Patients with acute liver injury (such as hepatitis) or severe (Child-Pugh Class C) cirrhosis will be excluded
Have an acute or chronic medical illness with the main symptoms of nausea or gastrointestinal discomfort or taking any medication known to have major gastric effects that would interfere with nausea ratings.
Electroconvulsive therapy (ECT) or Transcranial Magnetic Stimulation (TMS) within the past year
Taking any excluded medications within 7 days prior to Randomization.
Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Randomization or potential need to use a MAOI within 5 days after discontinuation of study drug.
Treatment with fluoxetine within 30 days prior to Randomization.
Frequent and/or severe allergic reactions with multiple medications or known hypersensitivity to duloxetine.
+1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead
Boehringer Ingelheimcollaborator

Study Sites (7)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Cheong Ju-City, 361-711, South Korea

Location

Goyang-si, 410-719, South Korea

Location

Seongnam-si, 463-707, South Korea

Location

Seoul, 134-791, South Korea

Location

Sungnam-Si, 463-712, South Korea

Location

Suwon, 442-721, South Korea

Location

Yangsan, 626-770, South Korea

Location

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

Limitations and Caveats

Large number of protocol violations; bias due to unblinded, open-label design (participants were predisposed to expect an outcome of nausea as the primary endpoint); use of emetogenic medications; incorrect reporting and intake of food and drug.

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5hours, EST)
Eli Lilly and Company
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 17, 2009

First Posted

August 18, 2009

Study Start

August 1, 2009

Primary Completion

February 1, 2011

Study Completion

April 1, 2011

Last Updated

December 31, 2014

Results First Posted

April 17, 2012

Record last verified: 2014-12

Locations

KR(7)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Study Arms (4)

Duloxetine 60 mg with food

Duloxetine 60 mg without food

Duloxetine 30 mg with food

Duloxetine 30 mg without food

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations