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

2018-11-09

Primary completion

2021-09-30

Completion

2021-09-30

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo + ADT vs Cariprazine 1.5 mg/Day + ADT; p = 0.0050; Least Squares Mean Difference -2.5 (95% CI -4.17 to -0.89) NCT03738215 ↗

paper At week 6, the mean reduction from baseline in MADRS total score was significantly greater with cariprazine 1.5 mg/day than with placebo (-14.1 vs. -11.5) PMID 36789515 ↗

Publications

• Fava M, Masand PS, Maletic V, Chen C, Adams JL, Kerolous M. Efficacy of Adjunctive Cariprazine on Anxiety Symptoms in Patients With Major Depressive Disorder: Post Hoc Analysis of a Randomized Placebo-Controlled Trial. J Clin Psychiatry. 2025 Apr 30;86(2):24m15506. doi: 10.4088/JCP.24m15506.
• Sachs GS, Yeung PP, Rekeda L, Khan A, Adams JL, Fava M. Adjunctive Cariprazine for the Treatment of Patients With Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study. Am J Psychiatry. 2023 Mar 1;180(3):241-251. doi: 10.1176/appi.ajp.20220504. Epub 2023 Feb 15.

Drugs

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

Indications