Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder

Summary

To examine the efficacy and safety of aripiprazole versus placebo as an adjunctive therapy co-administered with either an selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI) in patients with major depressive disorder.

Timeline

Start

2009-03

Primary completion

2012-07

Completion

2012-07

Outcome

Met primary endpoint

registry analysis (superiority or other test); Variable Dose Group of Aripiprazole vs Placebo Group; p = 0.006; Mean Difference (Final Values) -2.2 (95% CI -3.7 to -0.6); ANCOVA NCT00876343 ↗

registry analysis (superiority or other test); Fixed Dose Group of Aripiprazole vs Placebo Group; p <0.001; Mean Difference (Final Values) -3.1 (95% CI -4.6 to -1.5); ANCOVA NCT00876343 ↗

Publications

• Ozaki N, Otsubo T, Kato M, Higuchi T, Ono H, Kamijima K; ADMIRE Study Group. Efficacy of aripiprazole augmentation in Japanese patients with major depressive disorder: a subgroup analysis and Montgomery-Asberg Depression Rating Scale and Hamilton Rating Scale for Depression item analyses of the Aripiprazole Depression Multicenter Efficacy study. Psychiatry Clin Neurosci. 2015 Jan;69(1):34-42. doi: 10.1111/pcn.12214. Epub 2014 Aug 4.
• Kamijima K, Higuchi T, Ishigooka J, Ohmori T, Ozaki N, Kanba S, Kinoshita T, Koyama T; ADMIRE Study Group. Aripiprazole augmentation to antidepressant therapy in Japanese patients with major depressive disorder: a randomized, double-blind, placebo-controlled study (ADMIRE study). J Affect Disord. 2013 Dec;151(3):899-905. doi: 10.1016/j.jad.2013.07.035. Epub 2013 Aug 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aripiprazole	Other / unclassified	3 mg	Oral
Subject	Aripiprazole	Other / unclassified	15 mg	Oral

Indications