Steven G Potkin 1 , Jelena Kunovac 2,3 , Bernard L Silverman 4 , Adam Simmons 4 , Ying Jiang 4 , Lauren DiPetrillo 4 , David McDonnell 5,6 Show Affiliations »
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OBJECTIVE: To assess the antipsychotic efficacy and safety of a combination of olanzapine and samidorphan (OLZ/SAM ). METHODS: This 4-week, phase 3, randomized, double-blind, placebo - and olanzapine -controlled study was conducted from December 2015 to June 2017 in adults with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria who were experiencing an acute exacerbation . Patients were randomized 1:1:1 to OLZ/SAM, olanzapine monotherapy, or placebo . The primary and key secondary efficacy endpoint assessed was the change in Positive and Negative Syndrome Scale (PANSS) total score and Clinical Global Impressions-Severity of Illness Scale (CGI-S) score between baseline and week 4, respectively, for OLZ/SAM versus placebo . Safety monitoring occurred throughout. RESULTS: 401 patients received ≥ 1 dose of study drug; 352 completed treatment . Treatment with OLZ/SAM resulted in significant improvements versus placebo in PANSS total and CGI-S scores from baseline to week 4 (least squares [LS] mean ± SE: -6.4 ± 1.8 [P < .001] and -0.38 ± 0.12 [P = .002], respectively). Olanzapine treatment resulted in similar improvements (PANSS and CGI-S LS mean ± SE of -5.3 ± 1.84 [P = .004] and -0.44 ± 0.12 [P < .001], respectively). Adverse events (AEs ) occurred in 54.5%, 54.9%, and 44.8% of patients on OLZ/SAM , olanzapine , and placebo , respectively. Weight gain, somnolence, dry mouth, anxiety, and headache were the most common AEs (ie, ≥ 5%) with active treatment. CONCLUSIONS: OLZ/SAM treatment resulted in statistically and clinically significant efficacy improvements over 4 weeks versus placebo in adults with acutely exacerbated schizophrenia . Improvements were similar to those observed with olanzapine . OLZ/SAM was well tolerated, with a safety profile similar to that of olanzapine . TRIAL REGISTRATIONS: ClinicalTrials.gov identifier: NCT02634346; EudraCT number: 2015-003373 -15. © Copyright 2020 Physicians Postgraduate Press, Inc.
RCT Entities: Population
Interventions
Outcomes
OBJECTIVE: To assess the antipsychotic efficacy and safety of a combination of olanzapine and samidorphan (OLZ/SAM ). METHODS: This 4-week, phase 3, randomized, double-blind, placebo- and olanzapine -controlled study was conducted from December 2015 to June 2017 in adults with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders , Fifth Edition (DSM-5) criteria who were experiencing an acute exacerbation. Patients were randomized 1:1:1 to OLZ/SAM , olanzapine monotherapy, or placebo. The primary and key secondary efficacy endpoint assessed was the change in Positive and Negative Syndrome Scale (PANSS) total score and Clinical Global Impressions-Severity of Illness Scale (CGI-S) score between baseline and week 4, respectively, for OLZ/SAM versus placebo. Safety monitoring occurred throughout. RESULTS: 401 patients received ≥ 1 dose of study drug; 352 completed treatment. Treatment with OLZ/SAM resulted in significant improvements versus placebo in PANSS total and CGI-S scores from baseline to week 4 (least squares [LS] mean ± SE: -6.4 ± 1.8 [P < .001] and -0.38 ± 0.12 [P = .002], respectively). Olanzapine treatment resulted in similar improvements (PANSS and CGI-S LS mean ± SE of -5.3 ± 1.84 [P = .004] and -0.44 ± 0.12 [P < .001], respectively). Adverse events (AEs) occurred in 54.5%, 54.9%, and 44.8% of patients on OLZ/SAM , olanzapine , and placebo, respectively. Weight gain , somnolence , dry mouth , anxiety , and headache were the most common AEs (ie, ≥ 5%) with active treatment. CONCLUSIONS: OLZ/SAM treatment resulted in statistically and clinically significant efficacy improvements over 4 weeks versus placebo in adults with acutely exacerbated schizophrenia . Improvements were similar to those observed with olanzapine . OLZ/SAM was well tolerated, with a safety profile similar to that of olanzapine . TRIAL REGISTRATIONS: ClinicalTrials.gov identifier: NCT02634346; EudraCT number: 2015-003373-15. © Copyright 2020 Physicians Postgraduate Press, Inc.
Entities: Chemical
Disease
Species
Year: 2020
PMID： 32141723 DOI： 10.4088/JCP.19m12769
Source DB: PubMed Journal: J Clin Psychiatry ISSN： 0160-6689 Impact factor: 4.384