The Objective of This Study is to Evaluate the Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone

Summary

The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD who have had an inadequate response to antidepressants alone.

Timeline

Start

2018-11-10

Primary completion

2021-09-06

Completion

2021-09-06

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo + ADT vs Cariprazine 1.5 mg/Day + ADT; p = 0.6798 NCT03739203 ↗

registry analysis (superiority test); Placebo + ADT vs Cariprazine 3 mg/Day + ADT; p = 0.1245 NCT03739203 ↗

Publications

• Riesenberg R, Yeung PP, Rekeda L, Sachs GS, Kerolous M, Fava M. Cariprazine for the Adjunctive Treatment of Major Depressive Disorder in Patients With Inadequate Response to Antidepressant Therapy: Results of a Randomized, Double-Blind, Placebo-Controlled Study. J Clin Psychiatry. 2023 Aug 16;84(5):22m14643. doi: 10.4088/JCP.22m14643.

Drugs

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

Indications