Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder

NCT04819776 ↗

Phase 3 Completed 417 enrolled Vanda Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The aim of this study is to investigate the efficacy, safety, and tolerability of iloperidone compared with placebo in treating acute manic or mixed episodes associated with Bipolar I Disorder.

Timeline

Start: 2021-03-22
Primary completion: 2022-09-07
Completion: 2023-08-16

Outcome

Met primary endpoint

paper Iloperidone demonstrated significant improvement versus placebo at week 4 for the primary and secondary endpoints. PMID 38236020 ↗

paper Differences in the least-squares mean (95% CI; P value) of change from baseline for YMRS total scores were -4.0 (-5.70 to -2.25; adjusted P = .000008). PMID 38236020 ↗

Publications

Torres R, Czeisler EL, Chadwick SR, Stahl SM, Smieszek SP, Xiao C, Polymeropoulos CM, Birznieks G, Polymeropoulos MH. Efficacy and Safety of Iloperidone in Bipolar Mania: A Double-Blind, Placebo-Controlled Study. J Clin Psychiatry. 2024 Jan 15;85(1):23m14966. doi: 10.4088/JCP.23m14966.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Iloperidone	Small molecule	24 mg	Oral