Clinical trial NCT00960986: A Duloxetine Dosing Strategy Study in Korean Patients With Major Depressive Disorder
Official title: A Phase 4 Comparison of Duloxetine Dosing Strategies in the Treatment of Korean Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder (MDD)
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Boehringer Ingelheim
First posted: 2009-08-18
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.
* 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.
* Abnormal thyroid stimulating hormone (TSH) concentration. Note: Participants diagnosed with hyperthyroidism or hypothyroidism who were treated with a stable dose of thyroid supplement for at least the past 3 months, have medically appropriate TSH concentration, and are clinically euthyroid, are allowed to enroll in this study.

Primary outcomes:
measure: Mean Maximum Nausea Severity, Association for Methodology and Documentation in Psychiatry (AMDP-5) Adverse Event (AE) Scale Item 112 (Nausea)
timeFrame: 1 week and 8 weeks
Secondary outcomes:
measure: 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)
timeFrame: Baseline, 8 weeks
measure: 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
timeFrame: Baseline, 1 week and 8 weeks
measure: 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
timeFrame: Baseline, 1 week, 8 weeks
measure: Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score
timeFrame: Baseline, 1 week, 8 weeks
measure: Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale
timeFrame: Baseline, 1 week, 8 weeks
measure: Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Core Mood Subscale
timeFrame: Baseline, 1 week, 8 weeks
measure: Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Anxiety/Somatization Subscale
timeFrame: Baseline, 1 week, 8 weeks
measure: Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Retardation/Somatization Subscale
timeFrame: Baseline, 1 week, 8 weeks
measure: Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Sleep Subscale
timeFrame: Baseline, 1 week, 8 weeks
measure: Mean Change From Baseline to 1-Week and 8-Week Endpoints in Clinical Global Impressions of Severity (CGI-S)
timeFrame: Baseline, 1 week, 8 weeks
measure: Patient Global Impression of Improvement (PGI-I) at 1 Week and 8 Weeks
timeFrame: 1 week, 8 weeks
measure: Time to Onset of Nausea
timeFrame: Baseline to onset of nausea (Baseline up to 8 weeks)
measure: Time to Resolve Nausea
timeFrame: Nausea onset up to nausea resolve (Baseline up to 8 weeks)
measure: Percentage of Participants Achieving Response
timeFrame: Baseline up to 8 weeks
measure: Percentage of Patients Achieving Remission
timeFrame: Baseline up to 8 weeks
Other outcomes:
Locations:
city: Cheong Ju-City
country: Korea, Republic of
facility: 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.
city: Goyang-Si
country: Korea, Republic of
facility: 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.
city: Seongnam-Si
country: Korea, Republic of
facility: 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.
city: Seoul
country: Korea, Republic of
facility: 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.
city: Sungnam-Si
country: Korea, Republic of
facility: 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.
city: Suwon-City
country: Korea, Republic of
facility: 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.
city: Yangsan
country: Korea, Republic of
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5hours, EST)
role: STUDY_DIRECTOR
References: