A 6-Week, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Risperidone in Adolescents with Schizophrenia

Haas, Magali; Unis, Alan S.; Armenteros, Jorge L.; Copenhaver, Margaret D.; Quiróz, Jorge A.; Kushner, Stuart

doi:10.1089/cap.2008.0144

Cited by 114 publications

(81 citation statements)

References 28 publications

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“…Our subjects were 1-2 years younger than the 3.5-4 years age typical of puberty onset and an accompanying growth spurt in male macaque monkeys. Other findings of no excessive weight gain in many young children treated with risperidone (Fraguas et al 2008;Haas et al 2009) suggest that our result is not too surprising. Also, our adequate but not excessive monkey chow diet, supplemented with fruits and vegetables, does not lend itself to overeating or excessive caloric intake.…”

Section: Discussionsupporting

confidence: 49%

“…Placebo was given to all animals during weeks 1-2 of the postdrug phase, and then all treats were discontinued. These dose levels are in the low-to-moderate dose equivalence by body weight for children (e.g., Fraguas et al 2008;Haas et al 2009). …”

Section: Group Assignment and Dosingmentioning

confidence: 99%

“…Excessive weight gain is often reported, but two recent studies showed that not all children or adolescents exhibit it. Fraguas et al (2008) found excessive weight gain in only 50% of 66 patients and Haas et al (2009) found somewhat higher, but not excessive, weight gain for 106 adolescents treated with risperidone compared with placebo. Quetiapine, the most widely prescribed atypical, is approved in adults for treatment of schizophrenia, bipolar disorder, and major depression.…”

Section: Introductionmentioning

confidence: 97%

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Some Effects of Risperidone and Quetiapine on Growth Parameters and Hormone Levels in Young Pigtail Macaques

Sackett

Unis²,

Crouthamel³

2010

Journal of Child and Adolescent Psychopharmacology

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Objective: Atypical antipsychotic drugs are prescribed to young children for a number of symptoms, some with no Food and Drug Administration approval for children. Effects on growth of children have received little experimental study. We assessed the effects of two atypicals, risperidone and quetiapine, on growth, prolactin, and thyroid hormones of young pigtail macaques (macaca nemestrina), modeling potential effects on 4-8-year-old children. Methods: Subjects were studied blindly after random assignment to risperidone (N ¼ 10), quetiapine (N ¼ 10), or placebo (N ¼ 20). Four phases were studied: (1) predrug, 9-12 months of age; (2) low dose (risperidone 0.025 mg/kg, quetiapine 2 mg/ kg), 13-16 months; (3) high dose (risperidone 0.05 mg/kg, quetiapine 4 mg/kg), 17-20 months; (4) postdrug, 21-24 months. Body weight was measured daily, skeletal dimension monthly, and bone mineralization and hormones bimonthly. Results: Our primary result showed that, compared with placebo, neither drug had detrimental effects on body weight, skeletal dimensions, or thyroid hormones. However, in a transient effect, bone density was lower following low-dose risperidone than either quetiapine or placebo. In both drug phases, risperidone prolactin was higher than the other groups, which did not differ. The higher prolactin of the risperidone group may partially explain the bone density effect. Conclusion: This 16-month study of young, developing pigtail macaques given risperidone at doses from 0.025 to 0.05 mg/kg or quetiapine at doses from 2 to 4 mg/kg suggests that these drugs are safe for normal body weight and skeletal growth in young pigtail macaques given an adequate diet, although these drugs are known to cause significant weight gain and other metabolic changes in some children, adolescents, and adult humans. In addition, the results, although transient in our study, also suggest that research in children on bone mineralization effects of risperidone, and possibly other antipsychotic drugs, may be warranted.

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Section: Discussionsupporting

confidence: 49%

Section: Group Assignment and Dosingmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 97%

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Some Effects of Risperidone and Quetiapine on Growth Parameters and Hormone Levels in Young Pigtail Macaques

Sackett

Unis²,

Crouthamel³

2010

Journal of Child and Adolescent Psychopharmacology

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“…Other adverse effects, such as weight gain, may be similar in patients treated with the lower doses (0.5 to 2.5 mg) typically used to treat disruptive and aggressive behaviour, compared with higher doses (3 to 6 mg). 50,51 For children and adolescents with behavioural problems associated with ADHD who have inadequate response or intolerable adverse effects with ADHD medications and risperidone, little evidence is available to guide subsequent pharmacotherapy. Similarly, aside from data on risperidone, little evidence is available to guide pharmacotherapy for children and adolescents with disruptive or aggressive Canadian Guidelines on Pharmacotherapy for Disruptive and Aggressive Behaviour in Children and Adolescents With ADHD, ODD, or CD behaviour in the absence of ADHD.…”

mentioning

confidence: 99%

Canadian Guidelines on Pharmacotherapy for Disruptive and Aggressive Behaviour in Children and Adolescents with Attention-Deficit Hyperactivity Disorder, Oppositional Defiant Disorder, or Conduct Disorder

et al. 2015

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Objective: To develop evidence-based guidelines on pharmacotherapy for severe disruptive and aggressive behaviour in children and adolescents with attention-deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), or conduct disorder (CD). The guidelines assume that psychosocial interventions have been pursued but did not achieve sufficient improvement. Method:A multidisciplinary consensus group used the Grading of Recommendations Assessment, Development and Evaluation approach for rating evidence quality and for grading recommendations. We conducted a systematic review of medications studied in placebo-controlled trials for treating disruptive and aggressive behaviour in children and adolescents with ADHD, ODD, or CD. We followed consensus procedures to make 1 of 4 recommendations for each medication: strong, in favour (↑↑); conditional, in favour (↑?); conditional, against (↓?); and strong, against (↓↓).Results: For children and adolescents with disruptive or aggressive behaviour associated with ADHD, psychostimulants received a strong recommendation in favour of use, while atomoxetine and alpha-2 agonists received a conditional recommendation in favour of use. If these patients do poorly with ADHD medications, the medication with the most evidence is risperidone. Risperidone also has the most evidence for treating disruptive or aggressive behaviour in the absence of ADHD. However, given risperidone's major adverse effects, it received only a conditional recommendation in favour of use. We recommended against using quetiapine, haloperidol, lithium, or carbamazepine because of the poor quality of evidence and their major adverse effects. Conclusion:When severe disruptive or aggressive behaviour occurs with ADHD, medications for ADHD should be used first. Other medications have major adverse effects and, with the exception of risperidone, very limited evidence to support their use.W W W

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“…Some studies did not assess ECG modifications [36][37][38][39][40][41], and so a meta-analytic approach was not possible [12•]. In short-term studies, no effect on ECG was reported in 13 studies with risperidone [32,[42][43][44][45][46][47][48][49][50][51][52][53]. One study reported prolonged QT interval in one patient with risperidone [54].…”

Section: Lengthening Of the Qt Intervalmentioning

confidence: 99%

Management of Adverse Effects of Second-generation Antipsychotics in Youth

Raffin

Gianitelli

Consoli

et al. 2014

Curr Treat Options Psych

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Opinion statementSecond-generation antipsychotics (SGAs) have been proven effective in treating several psychiatric conditions in children and adolescents. These atypical antipsychotic medications are being used with increasing frequency in Europe, the U.S., and Canada. We aim to expose shortterm and long-term adverse effects (AEs) of SGAs in youth populations and to provide management recommendations for major adverse effects. These proposals are based on (1) an indepth literature review of both short-and long-term studies on the use of SGAs in youth; (2) our own clinical experience in managing such treatment in this population; and (3) the work of the Canadian Alliance for Monitoring Effectiveness and Safety of Antipsychotics in Children (CAMESA). AEs are frequent in youth treated with SGAs, and include primarily weight gain, metabolic and hormonal changes, somnolence, extrapyramidal syndrome, and QT modifications. However, frequency and type of AE vary according to compound, and each compound's AE profile is specific. Acknowledgment of these distinct profiles should aid clinicians in making treatment decisions. After an SGA is prescribed, routine monitoring of AEs is recommended, and should an AE occur, clinical management recommendations should be followed. To date, there are no clinically validated monitoring recommendations.

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A 6-Week, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Risperidone in Adolescents with Schizophrenia

Abstract: Risperidone 1-3 mg/day and 4-6 mg/day were well tolerated and effective in adolescents experiencing acute episodes of schizophrenia. The benefit-risk profile suggests that a dose of 1-3 mg/day might be optimal for this population.

Cited by 114 publications

References 28 publications

Some Effects of Risperidone and Quetiapine on Growth Parameters and Hormone Levels in Young Pigtail Macaques

Some Effects of Risperidone and Quetiapine on Growth Parameters and Hormone Levels in Young Pigtail Macaques

Canadian Guidelines on Pharmacotherapy for Disruptive and Aggressive Behaviour in Children and Adolescents with Attention-Deficit Hyperactivity Disorder, Oppositional Defiant Disorder, or Conduct Disorder

Management of Adverse Effects of Second-generation Antipsychotics in Youth

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