A Duloxetine Dosing Strategy Study in Korean Patients With Major Depressive Disorder

Lilly

Status and phase: Completed; Phase 4

Conditions: Major Depressive Disorder (MDD)

Treatments: Drug: Duloxetine hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00960986

9884

F1J-MC-HMFL (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 249 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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249 participants in 4 patient groups

Duloxetine 60 mg with food

Experimental group

Description:

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

Treatment:

Drug: Duloxetine hydrochloride

Duloxetine 60 mg without food

Experimental group

Description:

Duloxetine 60 mg capsule po QD without food for 8 weeks

Treatment:

Drug: Duloxetine hydrochloride

Duloxetine 30 mg with food

Experimental group

Description:

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

Treatment:

Drug: Duloxetine hydrochloride

Duloxetine 30 mg without food

Experimental group

Description:

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

Treatment:

Drug: Duloxetine hydrochloride