Clinical Trials/NCT00960986

NCT00960986

Completed

Phase 4

A Phase 4 Comparison of Duloxetine Dosing Strategies in the Treatment of Korean Patients With Major Depressive Disorder

Eli Lilly and Company1 site in 1 country249 target enrollmentAugust 2009

ConditionsMajor Depressive Disorder (MDD)

InterventionsDuloxetine hydrochloride

DrugsDuloxetine hydrochloride

Overview

Phase: Phase 4
Intervention: Duloxetine hydrochloride
Conditions: Major Depressive Disorder (MDD)
Sponsor: Eli Lilly and Company
Enrollment: 249
Locations: 1
Primary Endpoint: Mean Maximum Nausea Severity, Association for Methodology and Documentation in Psychiatry (AMDP-5) Adverse Event (AE) Scale Item 112 (Nausea)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

April 2011

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•17-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.

Exclusion Criteria

•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.

Arms & Interventions

Duloxetine 60 mg with food

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

Intervention: Duloxetine hydrochloride

Duloxetine 60 mg without food

Duloxetine 60 mg capsule po QD without food for 8 weeks

Intervention: Duloxetine hydrochloride

Duloxetine 30 mg with food

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

Intervention: Duloxetine hydrochloride

Duloxetine 30 mg without food

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

Intervention: Duloxetine hydrochloride

Outcomes

Primary Outcomes

Mean Maximum Nausea Severity, Association for Methodology and Documentation in Psychiatry (AMDP-5) Adverse Event (AE) Scale Item 112 (Nausea)

Time Frame: 1 week and 8 weeks

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.

Secondary Outcomes

Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Retardation/Somatization Subscale(Baseline, 1 week, 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 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 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)
Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Core Mood Subscale(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) Anxiety/Somatization Subscale(Baseline, 1 week, 8 weeks)
Percentage of Participants Achieving Response(Baseline up to 8 weeks)
Percentage of Patients Achieving Remission(Baseline up to 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 Clinical Global Impressions of Severity (CGI-S)(Baseline, 1 week, 8 weeks)
Patient Global Impression of Improvement (PGI-I) at 1 Week and 8 Weeks(1 week, 8 weeks)
Time to Resolve Nausea(Nausea onset up to nausea resolve (Baseline up to 8 weeks))
Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Sleep Subscale(Baseline, 1 week, 8 weeks)
Time to Onset of Nausea(Baseline to onset of nausea (Baseline up to 8 weeks))