Cited by 281Bipolar Disorder and TreatmentSchizophrenia research and treatmentPersonality Disorders and Psychopathology

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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

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Geller, Barbara·2012·Archives of General Psychiatry

DOI 10.1001/archgenpsychiatry.2011.1508PMC PMC3581342

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Abstract

CONTEXT: There was a paucity of comparative pharmacological research for initial treatment of bipolar I disorder, manic or mixed phase, in children and adolescents. OBJECTIVE: To investigate which medication to administer first to antimanic medication-naive subjects. DESIGN, SETTING, AND PARTICIPANTS: The 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. INTERVENTIONS: Subjects 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 MEASURES: Primary outcome measures were the Clinical Global Impressions for Bipolar Illness Improvement-Mania and the Modified Side Effects Form for Children and Adolescents. RESULTS: There 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). CONCLUSIONS: Risperidone was more efficacious than lithium or divalproex sodium for the initial treatment of childhood mania but had potentially serious metabolic effects. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00057681

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Authors: Geller, B.
Affiliations: Washington University in St. Louis (US)
Corresponding author: Geller, Barbara
Venue: Archives of General Psychiatry
Publisher: American Medical Association (AMA)
Published: 2012-05-01
Volume: 69
Issue: 5
Pages: 515
ISSN: 0003-990X (ISSN-L)
DOI: 10.1001/archgenpsychiatry.2011.1508
PMC: PMC3581342
OpenAlex: W2155569717
Cited by: 281
References: 38
Citations by year: 2026: 1 · 2025: 6 · 2024: 25 · 2023: 8 · 2022: 8 · 2021: 14 · 2020: 11 · 2019: 43 · 2018: 20 · 2017: 34 · 2016: 18 · 2015: 27 · 2014: 26 · 2013: 31 · 2012: 9
FWCI: 21.17
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: Archives of General Psychiatry (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Institutional Research Information System University of Turin (University of Turin) (submittedVersion)
Funders: National Institute of Mental Health (U01MH064869, U01MH064868, U01MH064846, U01MH064850, U01MH064851, R01MH051481, U01MH064911, U01MH064887)
Topics: Health Sciences › Medicine › Psychiatry and Mental health › Bipolar Disorder and Treatment
Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
Social Sciences › Psychology › Clinical Psychology › Personality Disorders and Psychopathology
Keywords: bipolar I disorder, manic phase, mixed phase, children and adolescents, risperidone, lithium, divalproex sodium, initial treatment, rapid cycling, treatment response, adverse effects, mood stabilizers, antipsychotic drugs
MeSH terms: Adolescent, Bipolar Disorder, Child, Female, Humans, Male, Psychiatric Status Rating Scales, Valproic Acid, Lithium Carbonate, Treatment Outcome, Antimanic Agents, Risperidone

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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

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