Safety and Efficacy from an 8 Week Double-Blind Trial and a 26 Week Open-Label Extension of Asenapine in Adolescents with Schizophrenia

Findling, Robert L.; Landbloom, Ronald; Mackle, Mary; Pallozzi, Wendi; Braat, Sabine; Hundt, Carla; Wamboldt, Marianne Z.; Mathews, Maju

doi:10.1089/cap.2015.0027

Cited by 41 publications

(25 citation statements)

References 24 publications

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“…For antipsychotics, we included three NMAs 101‐103 , 11 MAs 104‐114 , 25 individual RCTs 115‐139 also included in those NMA/MAs, three additional RCTs 140‐142 , and two cohort studies 99,143 . There were 66,764 youth on antipsychotics, including 7,712 across 53 RCTs after eliminating duplicated RCTs in multiple NMA/MAs (6,725 in NMA/MAs, 987 in additional RCTs), and 59,052 in two cohort studies.…”

Section: Resultsmentioning

confidence: 99%

Safety of 80 antidepressants, antipsychotics, anti‐attention‐deficit/hyperactivity medications and mood stabilizers in children and adolescents with psychiatric disorders: a large scale systematic meta‐review of 78 adverse effects

et al. 2020

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Mental disorders frequently begin in childhood or adolescence. Psychotropic medications have various indications for the treatment of mental disorders in this age group and are used not infrequently off‐label. However, the adverse effects of these medications require special attention during developmentally sensitive periods of life. For this meta‐review, we systematically searched network meta‐analyses and meta‐analyses of randomized controlled trials (RCTs), individual RCTs, and cohort studies reporting on 78 a priori selected adverse events across 19 categories of 80 psychotropic medications – including antidepressants, antipsychotics, anti‐attention‐deficit/hyperactivity disorder (ADHD) medications and mood stabilizers – in children and adolescents with mental disorders. We included data from nine network meta‐analyses, 39 meta‐analyses, 90 individual RCTs, and eight cohort studies, including 337,686 children and adolescents. Data on ≥20% of the 78 adverse events were available for six antidepressants (sertraline, escitalopram, paroxetine, fluoxetine, venlafaxine and vilazodone), eight antipsychotics (risperidone, quetiapine, aripiprazole, lurasidone, paliperidone, ziprasidone, olanzapine and asenapine), three anti‐ADHD medications (methylphenidate, atomoxetine and guanfacine), and two mood stabilizers (valproate and lithium). Among these medications with data on ≥20% of the 78 adverse events, a safer profile emerged for escitalopram and fluoxetine among antidepressants, lurasidone for antipsychotics, methylphenidate among anti‐ADHD medications, and lithium among mood stabilizers. The available literature raised most concerns about the safety of venlafaxine, olanzapine, atomoxetine, guanfacine and valproate. Nausea/vomiting and discontinuation due to adverse event were most frequently associated with antidepressants; sedation, extrapyramidal side effects, and weight gain with antipsychotics; anorexia and insomnia with anti‐ADHD medications; sedation and weight gain with mood stabilizers. The results of this comprehensive and updated quantitative systematic meta‐review of top‐tier evidence regarding the safety of antidepressants, antipsychotics, anti‐ADHD medications and mood stabilizers in children and adolescents can inform clinical practice, research and treatment guidelines.

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Section: Resultsmentioning

confidence: 99%

Safety of 80 antidepressants, antipsychotics, anti‐attention‐deficit/hyperactivity medications and mood stabilizers in children and adolescents with psychiatric disorders: a large scale systematic meta‐review of 78 adverse effects

et al. 2020

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“…c For weight and BMI, the effects were considered small when gains were approximately <1.5 kg and <1 kg/m 2 , respectively. 39,43,53,54,57,58,62,64,75,77,86,90,94,97,98,113,124,133,138,139,148 No 49,52,62,113,114,138 Not estimable 98 No significant difference Abbreviations: BMI, body mass index; CI, confidence interval; CrI, credible interval; EPS, extrapyramidal symptoms; FGA, first-generation antipsychotic; G1, group 1; G2, group 2; MD, mean difference; RR, risk ratio; SGA, second-generation antipsychotic.…”

Section: Fgas Versus Sgasmentioning

confidence: 99%

“…95% CI, 1.11 to 1.9826-28,33,39,43,49,50,53,54,59- 64,75,79,80,86,89,90,94,98,102,113,114,124,130,133,134,138,139,141,145,148 95% CI, 0.44 to 0.9133,49,57,62,64,75,86,89,90,94,98,113,120,134,138,148 95% CrI, 2.49 to 5.23[57][58][59][60][62][63][64]75,80,90,98,113,114,133,138,141,145 95% CrI, 2.27 to 3.8627,33,39,53,54,58,60,62- 64,75,77,86,90,94,98,102,113,114,124,130,133,134,139,145,148 …”

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confidence: 99%

Harms of Antipsychotics in Children and Young Adults: A Systematic Review Update

et al. 2018

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“…The model was fitted utilizing data from the two Phase I PK studies (A7501022 and P06522) and two fixed-dose Phase III studies evaluating the efficacy and safety of asenapine in pediatric patients. One was a 3-week study in patients aged 10–17 years with manic or mixed episodes associated with bipolar I disorder receiving asenapine 2.5, 5, or 10 mg BID (P06107; NCT01244815),14 and the other was an 8-week study in patients aged 12–17 years with schizophrenia receiving asenapine 2.5 or 5 mg BID (P05896; NCT01190254) 16. The model development, refinement, and evaluation process is shown in Figure S1.…”

Section: Methodsmentioning

confidence: 99%

Asenapine pharmacokinetics and tolerability in a pediatric population

Dogterom¹,

Riesenberg²,

Greef³

et al. 2018

DDDT

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PurposeThis study aimed to characterize the pharmacokinetic (PK) properties, safety, and tolerability of asenapine, and to develop a population PK model in pediatric patients with schizophrenia, bipolar disorder, or other psychiatric disorders.MethodsTwo Phase I multiple ascending-dose studies were conducted to evaluate the PK, safety, and tolerability of sublingual asenapine in pediatric patients (age 10–17 years) with schizophrenia or bipolar I disorder. Patients received asenapine 1–10 mg twice daily for up to 12 days. PK parameters (maximum concentration [Cmax], area under the curve from 0 to 12 hours [AUC0–12], time to Cmax [Tmax], and half-life) were summarized for asenapine with descriptive statistics, and safety parameters were collected. A population PK model, which included the two Phase I studies and two additional Phase III efficacy studies (asenapine 2.5–10 mg twice daily for up to 8 weeks, age 10–17 years), was developed using nonlinear mixed-effect modeling based on a previously developed adult PK model. The final model was used in simulations to obtain asenapine-exposure estimates across pediatric subgroups and to determine if intrinsic covariates warrant dose adjustments.ResultsThe PK of asenapine showed rapid absorption (Tmax ~1 hour) with an apparent terminal half-life between 16 and 32 hours. Increases in mean Cmax and AUC0–12 appeared to be dose-proportional in one study and near dose-proportional in the second study. Steady state was attained within 8 days. The most frequently occurring treatment-emergent adverse events were dysgeusia, sedation, and oral hypoesthesia. Simulation-based estimates of Cmax and AUC0–12 were similar for pediatric and adult patients; age, body-mass index, race, and sex were not associated with changes in asenapine exposure.ConclusionAsenapine was generally safe and well tolerated in pediatric patients aged 10–17 years. PK and safety data were similar to that observed in the adult population. Intrinsic factors had no significant impact on asenapine exposure, indicating there is no need for dose adjustments in the pediatric population.

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Safety and Efficacy from an 8 Week Double-Blind Trial and a 26 Week Open-Label Extension of Asenapine in Adolescents with Schizophrenia

Abstract: NCT01190254 and NCT1190267 at ClinicalTrials.gov.

Cited by 41 publications

References 24 publications

Safety of 80 antidepressants, antipsychotics, anti‐attention‐deficit/hyperactivity medications and mood stabilizers in children and adolescents with psychiatric disorders: a large scale systematic meta‐review of 78 adverse effects

Safety of 80 antidepressants, antipsychotics, anti‐attention‐deficit/hyperactivity medications and mood stabilizers in children and adolescents with psychiatric disorders: a large scale systematic meta‐review of 78 adverse effects

Harms of Antipsychotics in Children and Young Adults: A Systematic Review Update

Asenapine pharmacokinetics and tolerability in a pediatric population

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