Trial reportPsychopharmacology2016
Efficacy and safety of asenapine in Asian patients with an acute exacerbation of schizophrenia: a multicentre, randomized, double-blind, 6-week, placebo-controlled study.
Trial report in Psychopharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01098110 (A Multicenter, Randomized, Double-blind, Fixed-dose, 6-week Trial of the Efficacy and Safety of Asenapine Compared With Placebo in Subjects With an Acute Exacerbation of Schizophrenia), which is not on this map. Cited by 22 papers, 7 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicenter, Randomized, Double-blind, Fixed-dose, 6-week Trial of the Efficacy and Safety of Asenapine Compared With Placebo in Subjects With an Acute Exacerbation of Schizophrenia (Phase 3)
Who cites it
22 citing papers in PubMed, 7 syntheses or guidelines pooled it.
- Antipsychotic Drugs and Dysregulated Glucose Homeostasis: A Systematic Review and Meta-Analysis.JAMA psychiatry · 2025Pooled it
- Optimal dose for the efficacy of asenapine in patients with schizophrenia: Real-world data.Neuropsychopharmacology reports · 2024Pooled it
- Antipsychotic-Induced Weight Gain: Dose-Response Meta-Analysis of Randomized Controlled Trials.Schizophrenia bulletin · 2022Pooled it
- Examining Side Effect Variability of Antipsychotic Treatment in Schizophrenia Spectrum Disorders: A Meta-analysis of Variance.Schizophrenia bulletin · 2021Pooled it
- Meta-analysis of Dropout Rates in Placebo-Controlled Randomized Clinical Trials of Atypical Antipsychotics Assessed by PANSS.Clinical drug investigation · 2019Pooled it
- Medication-Induced Akathisia with Newly Approved Antipsychotics in Patients with a Severe Mental Illness: A Systematic Review and Meta-Analysis.CNS drugs · 2019Pooled it
- Meta-analysis of Placebo Response in Randomized Clinical Trials of Antipsychotic Drugs Using PANSS Focusing on Different Approaches to the Handling of Missing Data.Clinical drug investigation · 2018Pooled it
- A phase II study of ME2136 (Asenapine Maleate) plus standard antiemetic therapy for patients, including diabetic patients, receiving cisplatin-based chemotherapy.Investigational new drugs · 2024Trial
- Effect of single-administration of D-sorbitol pretreatment on the bitterness and continued willingness to take asenapine: a randomized, single-blind, placebo-controlled, crossover trial.BMC psychiatry · 2024Trial
- Efficacy of HP-3070, A Once-Daily Asenapine Transdermal System, in the Treatment of Adults with Schizophrenia: A PANSS Five-Factor Analysis.Neuropsychiatric disease and treatment · 2024Trial
- Long-term safety and efficacy of sublingual asenapine for the treatment of schizophrenia: A phase III extension study with follow-up for 52 weeks (P06125)-Secondary publication.Neuropsychopharmacology reports · 2023Trial
- Sensory evaluation of the bitterness of asenapine using D-sorbitol pretreatment: single-blind, placebo-controlled, crossover trial.BMC psychiatry · 2023Trial
- Early improvements of individual symptoms as a predictor of treatment response to asenapine in patients with schizophrenia.Neuropsychopharmacology reports · 2020Trial
- Efficacy and Safety of Cariprazine, Asenapine, Xanomeline-Trospium, and Lumateperone for Acute Exacerbations of Schizophrenia in Adults: A Network Meta-Analysis.Schizophrenia bulletin open · 2025Article
- Predictors of continuation for asenapine from real-world data in patients with schizophrenia.Annals of general psychiatry · 2024Article
- Onset of Action of Selected Second-Generation Antipsychotics (Pines)-A Systematic Review and Meta-Analyses.Biomedicines · 2022Review
- Satisfaction Survey on Antipsychotic Formulations by Schizophrenia Patients in Japan.Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2021Article
- Antipsychotics for negative and positive symptoms of schizophrenia: dose-response meta-analysis of randomized controlled acute phase trials.NPJ schizophrenia · 2021Review
- Treatment Continuation of Asenapine or Olanzapine in Japanese Schizophrenia Patients: A Propensity Score Matched Study.Neuropsychiatric disease and treatment · 2021Article
- Asenapine: an atypical antipsychotic with atypical formulations.Therapeutic advances in psychopharmacology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
rationaleAsenapine is a second generation anti-psychotic approved in the USA in 2009 for the treatment of schizophrenia, but its efficacy has not been proven in Asian patients.
objectivesThe objectives of this study are to evaluate the efficacy and tolerability of asenapine in Asian patients experiencing an acute exacerbation of schizophrenia.
methodsIn this prospective, double-blind study, patients in Japan, Korea, and Taiwan were randomized (1:1:1) to asenapine 5 mg twice daily (bid), 10 mg bid or placebo for 6 weeks after a 3- to 7-day washout/screening period. The primary endpoint was the mean change in the positive and negative syndrome scale (PANSS) total score from baseline to day 42/treatment end.
resultsOf the 532 participants randomized, 530 received treatment. The primary endpoint was significantly greater with asenapine 5 and 10 mg bid than with placebo (-12.24 and -14.17 vs. -0.95; p < 0.0001). The results of secondary endpoints including PANSS negative subscale scores and PANSS responders at the end of treatment supported the results of the primary endpoint. There were no significant differences in the incidence of treatment-emergent adverse events reported with asenapine 5 and 10 mg bid and placebo (84.6, 80.7, and 81.6 %). There was a mean (± standard deviation) change in weight of -1.76 ± 2.45 kg for placebo, +0.42 ± 2.65 kg for asenapine 5 mg bid, and +0.81 ± 2.89 kg for asenapine 10 mg bid group.
conclusionsAsenapine was effective and generally well tolerated when used for the treatment of acute exacerbations of schizophrenia in Asian patients.
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