Conditions: Depressive Disorder, Major
Allocation:  | Intervention model: PARALLEL
Enrollment: 242
Healthy volunteers: no

Brief summary:
The purpose of this study is to help answer the following research question: Whether switching to duloxetine improves depressed mood when current treatment did not work well for patients with depression.

Detailed description:

Arms:
arm 1: Patients who met criteria in Study Period I (screening) were treated with duloxetine 60 milligrams (mg) once daily (QD) in an open-label manner for 4 weeks (Study Period II). Study Period II was considered the acute therapy period. Study Period III was a 4-week interval where patients who did not respond during Study Period II had their duloxetine doses optimized to 120 mg.

Interventions: intervention 1: Duloxetine
Intervention descriptions: intervention 1: Study Period II (Acute Therapy): 60 mg capsules, QD, for 4 weeks.

Study Period III (Optimization): Responder group - 60 mg capsules, QD, for 4 weeks more. Non-responder group - 120 mg capsules, QD, for 4 weeks more.

Protocol document: