A Phase III Study of SM-13496 in Patients With Bipolar I Depression.

Summary

The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with Bipolar I Depression.

Timeline

Start

2014-02-19

Primary completion

2017-02-01

Completion

2017-02-16

Outcome

Mixed primary results

paper Lurasidone treatment significantly reduced mean MADRS total scores from baseline to Week 6 for the 20-60-mg/day group (-13.6; adjusted P = 0.007; effect size = 0.33), PMID 32827348 ↗

paper but not for the 80-120-mg/day group (-12.6; adjusted P = 0.057; effect size = 0.22) compared with placebo (-10.6). PMID 32827348 ↗

Publications

• Results Kato T, Ishigooka J, Miyajima M, Watabe K, Fujimori T, Masuda T, Higuchi T, Vieta E. Double-blind, placebo-controlled study of lurasidone monotherapy for the treatment of bipolar I depression. Psychiatry Clin Neurosci. 2020 Dec;74(12):635-644. doi: 10.1111/pcn.13137. Epub 2020 Sep 24.
• Hopkins SC, Tomioka S, Szabo ST, Koblan KS. A clinical trial inclusion criteria to enrich for patients presenting with canonical symptom structure in bipolar depression. Contemp Clin Trials. 2024 Oct;145:107644. doi: 10.1016/j.cct.2024.107644. Epub 2024 Aug 3.
• Kishi T, Nakamura H, Kato T, Iwata N. A diagnostic test to examine early improvement as a predictor of later response to lurasidone in bipolar depression. Neuropsychopharmacol Rep. 2023 Mar;43(1):137-140. doi: 10.1002/npr2.12319. Epub 2023 Jan 12.
• Kishi T, Yoshimura R, Sakuma K, Okuya M, Iwata N. Lurasidone, olanzapine, and quetiapine extended-release for bipolar depression: A systematic review and network meta-analysis of phase 3 trials in Japan. Neuropsychopharmacol Rep. 2020 Dec;40(4):417-422. doi: 10.1002/npr2.12137. Epub 2020 Sep 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lurasidone	Small molecule	20 mg	Oral
Subject	Lurasidone	Small molecule	60 mg	Oral
Subject	Lurasidone	Small molecule	80 mg	Oral
Subject	Lurasidone	Small molecule	120 mg	Oral

Indications