A Study Comparing the Efficacy and Safety of Duloxetine and Placebo for the Treatment of Depression in Elderly Patients
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Intervention: duloxetine hydrochloride; placebo
Intervention description: Placebo for 1 week (double-blind placebo lead-in), then duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.; Placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 370.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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