Conditions: Major Depressive Disorder
Keywords: MDD Major Depressive Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1022
Healthy volunteers: no

Brief summary:
The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD

Detailed description:

Arms:
arm 1: Antidepressant therapy (ADT) as prescribed by the investigator plus single-blind placebo for 8 weeks. arm 2: Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to dose-matched placebo, once per day, oral administration plus ADT for 8 weeks (up to Week 16). arm 3: Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to cariprazine, 1.5 to 4.5 milligrams (mg) per day, oral administration plus ADT for 8 weeks (up to Week 16). arm 4: Following the 8 week ADT plus single blind placebo lead-in period, participants who were ADT responders continued treatment with ADT plus placebo for an additional 8 weeks.

Interventions: intervention 1: Cariprazine intervention 2: Placebo intervention 3: Antidepressant Therapy (ADT)
Intervention descriptions: intervention 1: Cariprazine capsules 1.5 to 4.5 mg/day intervention 2: Dose-matched placebo capsule once per day intervention 3: ADT such as bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, paroxetine or vilazodone as prescribed by the physician.

Protocol document: