Trial Information

Summary: A Study Comparing the Efficacy and Safety of Duloxetine and Placebo for the Treatment of Depression in Elderly Patients

The purpose of this study is to compare the efficacy and safety of duloxetine 60 mg once daily to placebo on depression in elderly patients (greater than or equal to 65 years of age)

Patient Inclusion Criteria

• Ages Eligible for Study: 65 Years and above.
• Genders Eligible for Study: Both
• Are male or female outpatients at least 65 years of age who meet the DSM-IV-TR diagnostic criteria for MDD
• Have a MMSE score of at least 20 at Visit 1
• Have a degree of understanding such that the patient can communicate intelligibly with the investigator and study coordinator

Patient Exclusion Criteria

• Patients judged clinically to be at serious suicidal risk in the opinion of the investigator
• Have any prior history of bipolar disorder, panic disorder, psychosis, schizophrenia, or obsessive-compulsive disorder
• Have any current (within the past 12 months) DSM-IV-TR primary Axis I diagnosis other than MDD
• Have moderate to severe dementia
• Have a serious medical illness, including any CV, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require hospitalization within 6 months, in the opinion of the investigator

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Trial listings updated: June 1, 2008 at 6:30:28 AM