Trial reportBipolar disorders2010
Double-blind randomized trial of risperidone versus divalproex in pediatric bipolar disorder.
Trial report in Bipolar disorders, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 103 citations in OpenAlex.
- Drugs used in psychiatry causing an increase in body weight in children-a review.International journal of obesity (2005) · 2025Pooled it
- Psychopharmacological treatment of disruptive behavior in youths: systematic review and network meta-analysis.Scientific reports · 2023Pooled it
- Effectiveness, Adverse Effects and Drug Compliance of Long-Acting Injectable Risperidone in Children and Adolescents.Clinical drug investigation · 2017Trial
- Placebo-controlled trial of valproic Acid versus risperidone in children 3-7 years of age with bipolar I disorder.Journal of child and adolescent psychopharmacology · 2015Trial
- Safety, tolerability, and efficacy of quetiapine in youth with schizophrenia or bipolar I disorder: a 26-week, open-label, continuation study.Journal of child and adolescent psychopharmacology · 2013Trial
- A randomized controlled trial of risperidone, lithium, or divalproex sodium for initial treatment of bipolar I disorder, manic or mixed phase, in children and adolescents.Archives of general psychiatry · 2012Trial
- Pharmacotherapy impacts functional connectivity among affective circuits during response inhibition in pediatric mania.Behavioural brain research · 2012Trial
- Co-morbid disruptive behavior disorder and aggression predict functional outcomes and differential response to risperidone versus divalproex in pharmacotherapy for pediatric bipolar disorder.Journal of child and adolescent psychopharmacology · 2011Trial
- Research Status in Clinical Practice Regarding Pediatric and Adolescent Bipolar Disorders.Frontiers in psychiatry · 2022Review
- Efficacy and Safety of Adding Olanzapine to the Standard Preventive Regimen for Chemotherapy-induced Nausea and Vomiting in Children: A Randomized Double-blind Controlled Trial.Iranian journal of pharmaceutical research : IJPR · 2021Article
- Valproate for acute mania.The Cochrane database of systematic reviews · 2019Review
- Anticonvulsants for Psychiatric Disorders in Children and Adolescents: A Systematic Review of Their Efficacy.Frontiers in psychiatry · 2018Article
- Medication Adherence Among Adolescents with Bipolar Disorder.Journal of child and adolescent psychopharmacology · 2016Article
- Metabolic consequences of second-generation antipsychotics in youth: appropriate monitoring and clinical management.Adolescent health, medicine and therapeutics · 2014Review
- Aripiprazole for the treatment and prevention of acute manic and mixed episodes in bipolar I disorder in children and adolescents: a NICE single technology appraisal.PharmacoEconomics · 2013Review
- Possible mechanisms for the skeletal effects of antipsychotics in children and adolescents.Therapeutic advances in psychopharmacology · 2013Article
- The comorbidity of ADHD and bipolar disorder: any less confusion?Current psychiatry reports · 2013Review
- Systematic Review and Meta-analysis of Pharmacological Interventions for Weight Gain from Antipsychotics and Mood Stabilizers.Current psychiatry reviews · 2012Article
- Do we really know how to treat a child with bipolar disorder or one with severe mood dysregulation? Is there a magic bullet?Depression research and treatment · 2012Article
- Clinical usefulness of second-generation antipsychotics in treating children and adolescents diagnosed with bipolar or schizophrenic disorders.Paediatric drugs · 2011Review
Corrections and comments
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Authors and funding
8 authors at 5 institutions in 1 country.
Funding
Abstract
objectiveTo determine the relative effects of risperidone and divalproex in pediatric mania.
methodsThis is a double-blind, randomized, outpatient clinical trial with 66 children and adolescents (mean age= 10.9 ± 3.3 years; age range= 8-18 years) with mania who were randomly assigned to either risperidone (0.5-2 mg/day, n= 33) or divalproex (60-120 μg/mL, n= 33) for a six-week period. Measures included the Young Mania Rating Scale (YMRS) and Child Depression Rating Scale-Revised (CDRS-R).
resultsMixed-effects regression models, with interaction between time and the active drug as predictors, found that the risperidone group had more rapid improvement than the divalproex group (p < 0.05), although final scores did not differ significantly between groups. Mixed models using only those subjects who completed the six-week study found similar results. The response rate on YMRS was 78.1% for risperidone and 45.5% for divalproex (p < 0.01). The remission rate for risperidone was 62.5%, compared with 33.3% for divalproex (p < 0.05). Improvement on the CDRS-R was significantly higher for the risperidone group relative to the divalproex group (p < 0.05). There were no significant differences between groups in safety, but subject retention was significantly higher at study endpoint in the risperidone group (p < 0.01). Dropout rate was 24% in the risperidone group and 48% in the divalproex group, with increased irritability being the most common reason for dropout in the latter. There was no significant weight gain in either group.
conclusionResults suggest that risperidone was associated with more rapid improvement and greater reduction in manic symptoms compared to divalproex. Although the results suggest that both drugs are safe, risperidone's lower attrition rate and lower rate of adverse events may suggest better toleration. Clinical trials with larger samples are required to confirm these preliminary findings.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.