Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder

Summary

An outpatient study to evaluate the safety and efficacy of cariprazine as adjunct to antidepressant therapy (ADT) in participants with major depressive disorder (MDD) who have an inadequate response to ADT alone. This clinical study compared cariprazine + ADT with placebo + ADT in outpatients with a diagnosis of MDD and an inadequate response to ADT. The study consisted of approximately 2 weeks of screening and washout followed by 8 weeks of double-blind treatment followed by a 1 week safety follow-up.

Timeline

Start

2011-12-15

Primary completion

2013-12-12

Completion

2013-12-12

Outcome

Mixed primary results

registry analysis (superiority test); Placebo vs Cariprazine 1-2 mg; p = 0.2404; Least squares mean difference -0.9 (95% CI -2.4 to 0.6) NCT01469377 ↗

registry analysis (superiority test); Placebo vs Cariprazine 2-4.5 mg; p = 0.0114; Least squares mean difference -2.2 (95% CI -3.7 to -0.6) NCT01469377 ↗

Publications

• Durgam S, Earley W, Guo H, Li D, Nemeth G, Laszlovszky I, Fava M, Montgomery SA. Efficacy and safety of adjunctive cariprazine in inadequate responders to antidepressants: a randomized, double-blind, placebo-controlled study in adult patients with major depressive disorder. J Clin Psychiatry. 2016 Mar;77(3):371-8. doi: 10.4088/JCP.15m10070.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cariprazine	Small molecule	1 mg	Oral
Subject	Cariprazine	Small molecule	1.5 mg	Oral
Subject	Cariprazine	Small molecule	2 mg	Oral
Subject	Cariprazine	Small molecule	3 mg	Oral
Subject	Cariprazine	Small molecule	4.5 mg	Oral

Indications