Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder MDD Depression
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 840
Healthy volunteers: no

Brief summary:
This study investigates two different approaches to the change in antidepressant treatment when an initial treatment is not effective: early intervention or delayed intervention.

Two hypothesis will be tested:

1. that time to confirmed response is shorter in the early intervention strategy vs. delayed intervention strategy
2. that the time to confirmed remission is shorter in the early intervention strategy compared to delayed intervention strategy.

Detailed description:

Arms:
arm 1: Escitalopram 10 milligrams per day for 4 weeks (one 10 milligram \[mg\]-capsule) followed by Duloxetine flexible dose (60 or 120 mg daily) for 12 weeks. arm 2: Escitalopram 10 mg per day for 4 weeks (one 10 mg-capsule) followed by Escitalopram 10 to 20 mg per day for 4 weeks (one or two 10 mg capsule\[s\]). Then, non-responders switched to Duloxetine 60 or 120 mg per day for 8 weeks , and responders continued on Escitalopram 10 to 20 mg per day for 8 weeks.

Interventions: intervention 1: Duloxetine Hydrochloride intervention 2: Escitalopram
Intervention descriptions: intervention 1: Flexible dose of 60 or 120 mg daily intervention 2: 10 mg in both Early and Delayed Intervention. Flexible dose of 10 to 20 mg daily in Delayed Intervention.

Protocol document: