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

Phase 2 Completed 231 enrolled Forest Laboratories Gedeon Richter Ltd. · collab

RandomizedParallel-groupDouble-blindTreatment

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

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

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

Summary

Timeline

Publications

Drugs

Indications