Conditions: Major Depressive Disorder
Keywords: Depression
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 225
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether a reduced dose of aripiprazole is effective in treating patients with major depressive disorder

Detailed description:
This is a 60-day, multi-center, double-blind, placebo-controlled study on the efficacy of aripiprazole (Abilify) augmentation of selective serotonin reuptake inhibitors (SSRIs) or selective serotonin norepinephrine uptake inhibitors (SNRIs) venlafaxine in patients with MDD who have responded inadequately to treatment with ADTs. The purpose of our study is to evaluate the efficacy and tolerability of low-dose (2 mg/day) aripiprazole (Abilify) as an augmentation strategy in MDD non-responding to ADT with SSRIs or the SNRI venlafaxine.

Arms:
arm 1: patients randomly assigned to the drug/drug sequence, the dose of aripiprazole will be 2 mg/day during the first phase of the study, and 5 mg/day in the second phase. arm 2: For patients randomly assigned to the placebo/drug sequence, the dose of aripiprazole will be 2 mg/day during the second phase of the study. arm 3: for patients randomly assigned to the placebo/placebo sequence, study medication will be placebo during both phases of the study.

Interventions: intervention 1: Aripiprazole 5mg intervention 2: Aripiprazole 2mg intervention 3: Placebo
Intervention descriptions: intervention 1: Tablet dose of aripiprazole will be 2 mg/day during the first phase (30 days) of the study, and 5 mg/day in the second phase (30 days) intervention 2: For patients randomly assigned to the placebo/drug sequence, the dose of aripiprazole will be 2 mg/day during the second phase of the study (30 days) intervention 3: for patients randomly assigned to the placebo/placebo sequence, study medication will be placebo during both phases of the study (60 days)

Protocol document: