Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eli Lilly and Company
With
Boehringer Ingelheim
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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.
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.
You may not be 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.
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.
Clareo Health | A Duloxetine Dosing Strategy Study in Korean Patients With Major Depressive Disorder
