Trial reportArchives of general psychiatry2012
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.
Trial report in Archives of general psychiatry, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00057681 (Treatment of Early Age Mania), which is not on this map. Cited by 68 papers, 6 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.
Treatment of Early Age Mania (TEAM) Study
Who cites it
68 citing papers in PubMed, 6 syntheses or guidelines pooled it, 282 citations in OpenAlex.
- Treatment of Early-Onset Specified and Unspecified Bipolar Disorders: A Systematic Review and Strategies for Identifying and Managing a Thermally Dysregulated Subtype in Children.Acta psychiatrica Scandinavica · 2025Pooled it
- Use of Lithium in Pediatric Bipolar Disorders and Externalizing Childhood- related Disorders: A Systematic Review of Randomized Controlled Trials.Current neuropharmacology · 2023Pooled it
- Lithium for acute mania.The Cochrane database of systematic reviews · 2019Pooled it
- Putative Mechanisms of Action and Clinical Use of Lithium in Children and Adolescents: A Critical Review.Current neuropharmacology · 2019Pooled it
- Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder.Bipolar disorders · 2018Guideline
- Management of adverse effects of mood stabilizers.Current psychiatry reports · 2015Pooled it
- A Randomized, Double-Blind, Controlled Trial of Lithium Versus Quetiapine for the Treatment of Acute Mania in Youth with Early Course Bipolar Disorder.Journal of child and adolescent psychopharmacology · 2021Trial
- Classifying Mood Symptom Trajectories in Adolescents With Bipolar Disorder.Journal of the American Academy of Child and Adolescent Psychiatry · 2020Trial
- Comorbid sleep disorders and suicide risk among children and adolescents with bipolar disorder.Journal of psychiatric research · 2017Trial
- Depression and Suicidality Outcomes in the Treatment of Early Age Mania Study.Journal of the American Academy of Child and Adolescent Psychiatry · 2015Trial
- A Randomized Controlled Trial of Individual Family Psychoeducational Psychotherapy and Omega-3 Fatty Acids in Youth with Subsyndromal Bipolar Disorder.Journal of child and adolescent psychopharmacology · 2015Trial
- Lithium in the Acute Treatment of Bipolar I Disorder: A Double-Blind, Placebo-Controlled Study.Pediatrics · 2015Trial
- 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
- A prospective open-label trial of paliperidone monotherapy for the treatment of bipolar spectrum disorders in children and adolescents.Psychopharmacology · 2013Trial
- Post-acute effectiveness of lithium in pediatric bipolar I disorder.Journal of child and adolescent psychopharmacology · 2013Trial
- Treatment moderators and predictors of outcome in the Treatment of Early Age Mania (TEAM) study.Journal of the American Academy of Child and Adolescent Psychiatry · 2012Trial
- Trends in the Use of Atypical Antipsychotics Among Children and Adolescents With Bipolar Spectrum Disorders in Korea.Bipolar disorders · 2026Article
- Pediatric Bipolar Disorder: Challenges in Diagnosis and Treatment.Paediatric drugs · 2025Review
- Comparisons of mental health treatment frequency and risk of suicidal thoughts and behaviors among youth.Psychiatry research · 2024Article
- Efficacy and Safety of Lithium for Suicide and Suicide-Related Behaviors in Youth: A Review of the Literature.Brain sciences · 2024Review
8 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 1 institution in 1 country.
Funding
Abstract
contextThere was a paucity of comparative pharmacological research for initial treatment of bipolar I disorder, manic or mixed phase, in children and adolescents.
objectiveTo investigate which medication to administer first to antimanic medication-naive subjects. DESIGN, SETTING, AND
participantsThe Treatment of Early Age Mania (TEAM) study recruited 6- to 15-year-old children and adolescents with DSM-IV bipolar I disorder (manic or mixed phase) at 5 US sites from 2003 to 2008 into a controlled, randomized, no-patient-choice, 8-week protocol. Blinded, independent evaluators conducted all baseline and end-point assessments.
interventionsSubjects received a titrated schedule of lithium, divalproex sodium, or risperidone. Medications were increased weekly only if there was inadequate response, and no dose-limiting adverse effects, to maximum doses of lithium carbonate (1.1-1.3 mEq/L), divalproex sodium (111-125 μg/mL), and risperidone (4-6 mg).
main outcome measuresPrimary outcome measures were the Clinical Global Impressions for Bipolar Illness Improvement-Mania and the Modified Side Effects Form for Children and Adolescents.
resultsThere were 279 antimanic medication-naive subjects (mean [SD] age, 10.1 [2.8] years; 50.2% female) who had the following characteristics: 100% elated mood and/or grandiosity, 77.1% psychosis, 97.5% mixed mania, 99.3% daily rapid cycling, and mean (SD) mania duration of 4.9 (2.5) years. The mean (SD) titrated lithium level was 1.09 (0.34) mEq/L, and the mean (SD) divalproex sodium level was 113.6 (23.0) μg/mL. The mean (SD) titrated risperidone dose was 2.57 (1.21) mg. Higher response rates occurred with risperidone vs lithium (68.5% vs 35.6%; χ(2)(1) = 16.9, P < .001) and vs divalproex sodium (68.5% vs 24.0%; χ(2)(1) = 28.3, P < .001). Response to lithium vs divalproex sodium did not differ. The discontinuation rate was higher for lithium than for risperidone (χ(2)(1) = 6.4, P = .011). Increased weight gain, body mass index, and prolactin level occurred with risperidone vs lithium (F(1,212) = 45.5, P < .001; F(1,212) = 39.1, P < .001; and F(1,213) = 191.4, P < .001, respectively) and vs divalproex sodium (F(1,212) = 34.7, P < .001; F(1,212) = 45.3, P < .001; and F(1,213) = 209.4, P < .001, respectively). The thyrotropin level increased in subjects taking lithium (t(62) = 11.3, P < .001).
conclusionsRisperidone was more efficacious than lithium or divalproex sodium for the initial treatment of childhood mania but had potentially serious metabolic effects.
trial registrationclinicaltrials.gov Identifier: NCT00057681
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