Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder

Summary

This is an outpatient study to evaluate the safety, and efficacy of RGH-188 as an add-on therapy to standard antidepressants in patients who did not respond to previous antidepressant therapy.

Timeline

Start

2009-06-30

Primary completion

2010-12-06

Completion

2010-12-06

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Cariprazine 0.1 - 0.3 mg; p = 0.746; Least Squares Mean Difference 0.5 (95% CI -2.4 to 3.4); ANCOVA NCT00854100 ↗

registry analysis (superiority test); Placebo vs Cariprazine 1.0 - 2.0 mg; p = 0.227; Least Squares Mean Difference -1.8 (95% CI -4.8 to 1.1); ANCOVA NCT00854100 ↗

Publications

• Fava M, Durgam S, Earley W, Lu K, Hayes R, Laszlovszky I, Nemeth G. Efficacy of adjunctive low-dose cariprazine in major depressive disorder: a randomized, double-blind, placebo-controlled trial. Int Clin Psychopharmacol. 2018 Nov;33(6):312-321. doi: 10.1097/YIC.0000000000000235.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cariprazine	Small molecule	0.1 mg	Oral
Subject	Cariprazine	Small molecule	0.3 mg	Oral
Subject	Cariprazine	Small molecule	1 mg	Oral
Subject	Cariprazine	Small molecule	2 mg	Oral
Background	Citalopram	Small molecule	—	Oral
Background	Duloxetine	Small molecule	—	Oral
Background	Escitalopram	Small molecule	—	Oral
Background	Sertraline	Small molecule	—	Oral
Background	Venlafaxine	Small molecule	—	Oral

Indications