Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)

Summary

This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression

Timeline

Start

2009-04

Primary completion

2012-02

Completion

2012-02

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Lurasidone Low Arm; p <0.001; Mean Difference (Final Values) -4.6; Mixed Models Analysis NCT00868699 ↗

registry analysis (superiority or other test); Placebo vs Lurasidone High Arm; p <0.001; Mean Difference (Final Values) -4.6; Mixed Models Analysis NCT00868699 ↗

Publications

• Results Loebel A, Cucchiaro J, Silva R, Kroger H, Hsu J, Sarma K, Sachs G. Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014 Feb;171(2):160-8. doi: 10.1176/appi.ajp.2013.13070984.
• Goldberg JF, Siu C, Tocco M, Pikalov A, Loebel A. The Effect of Lurasidone on Anxiety Symptoms in Patients With Bipolar Depression: A Post Hoc Analysis. J Clin Psychiatry. 2023 Jun 7;84(4):22m14732. doi: 10.4088/JCP.22m14732.
• Raison CL, Pikalov A, Siu C, Tsai J, Koblan K, Loebel A. C-reactive protein and response to lurasidone in patients with bipolar depression. Brain Behav Immun. 2018 Oct;73:717-724. doi: 10.1016/j.bbi.2018.08.009. Epub 2018 Aug 10.
• Sajatovic M, Forester BP, Tsai J, Kroger H, Pikalov A, Cucchiaro J, Loebel A. Efficacy of Lurasidone in Adults Aged 55 Years and Older With Bipolar Depression: Post Hoc Analysis of 2 Double-Blind, Placebo-Controlled Studies. J Clin Psychiatry. 2016 Oct;77(10):e1324-e1331. doi: 10.4088/JCP.15m10261.
• Rajagopalan K, Bacci ED, Ng-Mak D, Wyrwich K, Pikalov A, Loebel A. Effects on health-related quality of life in patients treated with lurasidone for bipolar depression: results from two placebo controlled bipolar depression trials. BMC Psychiatry. 2016 May 23;16:157. doi: 10.1186/s12888-016-0865-y.
• Chapel S, Chiu YY, Hsu J, Cucchiaro J, Loebel A. Lurasidone Dose Response in Bipolar Depression: A Population Dose-response Analysis. Clin Ther. 2016 Jan 1;38(1):4-15. doi: 10.1016/j.clinthera.2015.11.013. Epub 2015 Dec 22.
• Loebel A, Siu C, Rajagopalan K, Pikalov A, Cucchiaro J, Ketter TA. Recovery in bipolar depression: Post-hoc analysis of a placebo-controlled lurasidone trial followed by a long-term continuation study. J Affect Disord. 2015 Nov 1;186:376-82. doi: 10.1016/j.jad.2015.07.033. Epub 2015 Aug 5.
• McIntyre RS, Cucchiaro J, Pikalov A, Kroger H, Loebel A. Lurasidone in the treatment of bipolar depression with mixed (subsyndromal hypomanic) features: post hoc analysis of a randomized placebo-controlled trial. J Clin Psychiatry. 2015 Apr;76(4):398-405. doi: 10.4088/JCP.14m09410.

Drugs

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

Indications