Safety and Effectiveness of SEP−363856 in Schizophrenia: Results of a 6-Month, Open-Label Extension Study. Correll, C. U., Koblan, K. S., Hopkins, S. C., Kent, J., Cheng, H., Goldman, R., & Loebel, A. CNS Spectrums, 26(2):148–149, April, 2021.
Safety and Effectiveness of SEP−363856 in Schizophrenia: Results of a 6-Month, Open-Label Extension Study [link]Paper  doi  abstract   bibtex   
Method. Patients 10–17 years with bipolar I depression who completed a 6-week double-blind (DB) study of lurasidone vs. placebo were eligible to enroll in a two-year, open-label (OL) extension study in which patients were continued on flexibly-dosed lurasidone (20–80 mg/d) or switched from placebo to lurasidone. Efficacy measures included the Children’s Depression Rating Scale, Revised (CDRS-R) and the Clinical Global Impression, Bipolar Depression Severity scale (CGI-BP-S). Functioning was evaluated utilizing the Clinician-rated Children’s Global Assessment Scale (CGAS) score, with a score \textgreater70 indicating no clinically meaningful functional impairment. Responder criteria were met if a patient achieved criteria = 50% reduction from DB baseline in the CDRS-R total score: remission criteria were met if a patient achieved a CDRS-R Total Score =28 and a YMRS total score =8 and CGI-BP-S depression score =3, and a patient was considered to have met recovery criteria if they achieved remission with a CGAS score \textgreater70. In addition, a more stringent outcome, sustained remission, was also analyzed, which required a patient to meet remission criteria for =24 consecutive weeks. Results. A total of 306 patients completed the 6-week DB study and entered the extension study; 195 (63.7%) patients completed one year of treatment and 168 (54.9%) patients completed two years of treatment. Responder rates at OL baseline, one year, and two years were: 51.0%, 88.4% and 91.1%, respectively; remission rates were 24.3%, 61.3%, and 75.6%, respectively; and recovery rates were 17.7%, 53.8%, and 73.8%. On a Pearson correlation analysis, there was a strong inverse relationship (r = À0.71) between CDRS-R total score, and global functioning as measured by the CGAS. Sustained remission was achieved by 37.2% of patients at one year and 57% of patients after two years. Conclusions. In children and adolescents with bipolar depression, up to 2 years of treatment with lurasidone was associated with continued improvement in depressive symptoms, resulting in progressively higher rates of response, remission, recovery, and the more rigorously calculated outcome of sustained remission.
@article{correll_safety_2021,
	title = {Safety and {Effectiveness} of {SEP}−363856 in {Schizophrenia}: {Results} of a 6-{Month}, {Open}-{Label} {Extension} {Study}},
	volume = {26},
	issn = {1092-8529, 2165-6509},
	shorttitle = {Safety and {Effectiveness} of {SEP}−363856 in {Schizophrenia}},
	url = {https://www.cambridge.org/core/product/identifier/S1092852920002357/type/journal_article},
	doi = {10.1017/S1092852920002357},
	abstract = {Method. Patients 10–17 years with bipolar I depression who completed a 6-week double-blind (DB) study of lurasidone vs. placebo were eligible to enroll in a two-year, open-label (OL) extension study in which patients were continued on flexibly-dosed lurasidone (20–80 mg/d) or switched from placebo to lurasidone. Efficacy measures included the Children’s Depression Rating Scale, Revised (CDRS-R) and the Clinical Global Impression, Bipolar Depression Severity scale (CGI-BP-S). Functioning was evaluated utilizing the Clinician-rated Children’s Global Assessment Scale (CGAS) score, with a score {\textgreater}70 indicating no clinically meaningful functional impairment. Responder criteria were met if a patient achieved criteria = 50\% reduction from DB baseline in the CDRS-R total score: remission criteria were met if a patient achieved a CDRS-R Total Score =28 and a YMRS total score =8 and CGI-BP-S depression score =3, and a patient was considered to have met recovery criteria if they achieved remission with a CGAS score {\textgreater}70. In addition, a more stringent outcome, sustained remission, was also analyzed, which required a patient to meet remission criteria for =24 consecutive weeks.
Results. A total of 306 patients completed the 6-week DB study and entered the extension study; 195 (63.7\%) patients completed one year of treatment and 168 (54.9\%) patients completed two years of treatment. Responder rates at OL baseline, one year, and two years were: 51.0\%, 88.4\% and 91.1\%, respectively; remission rates were 24.3\%, 61.3\%, and 75.6\%, respectively; and recovery rates were 17.7\%, 53.8\%, and 73.8\%. On a Pearson correlation analysis, there was a strong inverse relationship (r = À0.71) between CDRS-R total score, and global functioning as measured by the CGAS. Sustained remission was achieved by 37.2\% of patients at one year and 57\% of patients after two years.
Conclusions. In children and adolescents with bipolar depression, up to 2 years of treatment with lurasidone was associated with continued improvement in depressive symptoms, resulting in progressively higher rates of response, remission, recovery, and the more rigorously calculated outcome of sustained remission.},
	language = {en},
	number = {2},
	urldate = {2021-11-28},
	journal = {CNS Spectrums},
	author = {Correll, Christoph U. and Koblan, Kenneth S. and Hopkins, Seth C. and Kent, Justine and Cheng, Hailong and Goldman, Robert and Loebel, Antony},
	month = apr,
	year = {2021},
	pages = {148--149},
}
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