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

Lilly

Status and phase: Completed; Phase 4

Conditions: Major Depressive Disorder

Treatments: Drug: duloxetine hydrochloride; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00406848

F1J-US-HMFA (Other Identifier)

10815 (Other Identifier)

Details and patient eligibility

About

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). Patients who do not respond in the first 13 weeks will be eligible for rescue using pre-defined criteria. Patients randomized to duloxetine 60 mg/day meeting the rescue criteria will be increased to 120 mg/day. Patients randomized to the placebo arm meeting the rescue criteria will be assigned to duloxetine 60 mg/day.

Enrollment: 370 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are male or female outpatients at least 65 years of age who meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder (MDD)
• Have a Mini Mental Score Exam (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

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 cardiovascular (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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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370 participants in 2 patient groups, including a placebo group

Duloxetine

Experimental group

Treatment:

Drug: duloxetine hydrochloride

Placebo

Placebo Comparator group

Treatment:

Drug: placebo