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Aripiprazole in children and adolescents with bipolar disorder comorbid with attention-deficit/hyperactivity disorder: a pilot randomized clinical trial.
J Clin Psychiatry. 2009 Apr 21; 70(5):756-64.JC

Abstract

OBJECTIVE

To assess response to treatment with aripiprazole in children and adolescents with bipolar disorder comorbid with attention-deficit/hyperactivity disorder (ADHD).

METHOD

Children and adolescents were extensively assessed according to DSM-IV criteria for bipolar disorder comorbid with ADHD (n = 710). Those with this comorbidity who were acutely manic or in mixed states were randomly assigned in a 6-week double-blind, placebo-controlled trial to aripiprazole (n = 18) or placebo (n = 25). Primary outcome measures were assessed weekly and included the Young Mania Rating Scale; the Swanson, Nolan, and Pelham Scale-Version IV; and weight. Secondary outcome measures were the Clinical Global Impressions-Severity of Illness scale, the Child Mania Rating Scale-Parental Version (CMRS-P), the Children's Depression Rating Scale-Revised, the Kutcher Adolescent Depression Scale, and adverse events. The trial was conducted at the Hospital de Clínicas de Porto Alegre, Rio Grande do Sul, Brazil, from January 2005 to November 2007.

RESULTS

The group receiving aripiprazole showed a significantly greater reduction in YMRS scores (P = .02, effect size [ES] = 0.80), CMRS-P scores (P = .02; ES = 0.54), and CGI-S scores (P = .04; ES = 0.28) from baseline to endpoint than the placebo group. In addition, higher rates of response (P = .02) and remission (P = .01) were found for the aripiprazole group. No significant between-group differences were found in weight, ADHD symptoms, and depressive symptoms. Adverse events significantly more frequent in the aripiprazole group were somnolence and sialorrhea.

CONCLUSION

Aripiprazole was effective in reducing manic symptoms and improving global functioning without promoting severe adverse events or weight gain. No significant treatment effect in ADHD symptoms was observed. Studies are needed to assess psychopharmacologic interventions for improving ADHD symptoms in juvenile bipolar disorder comorbid with ADHD.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00116259.

Authors+Show Affiliations

Juvenile Bipolar Disorder Outpatient Program (ProCAB), Division of Child and Adolescent Psychiatry, Hospital de Clínicas de Porto Alegre, Federal University of Rio Grande do Sul, Brazil.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19389329

Citation

Tramontina, Silzá, et al. "Aripiprazole in Children and Adolescents With Bipolar Disorder Comorbid With Attention-deficit/hyperactivity Disorder: a Pilot Randomized Clinical Trial." The Journal of Clinical Psychiatry, vol. 70, no. 5, 2009, pp. 756-64.
Tramontina S, Zeni CP, Ketzer CR, et al. Aripiprazole in children and adolescents with bipolar disorder comorbid with attention-deficit/hyperactivity disorder: a pilot randomized clinical trial. J Clin Psychiatry. 2009;70(5):756-64.
Tramontina, S., Zeni, C. P., Ketzer, C. R., Pheula, G. F., Narvaez, J., & Rohde, L. A. (2009). Aripiprazole in children and adolescents with bipolar disorder comorbid with attention-deficit/hyperactivity disorder: a pilot randomized clinical trial. The Journal of Clinical Psychiatry, 70(5), 756-64. https://doi.org/10.4088/JCP.08m04726
Tramontina S, et al. Aripiprazole in Children and Adolescents With Bipolar Disorder Comorbid With Attention-deficit/hyperactivity Disorder: a Pilot Randomized Clinical Trial. J Clin Psychiatry. 2009 Apr 21;70(5):756-64. PubMed PMID: 19389329.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Aripiprazole in children and adolescents with bipolar disorder comorbid with attention-deficit/hyperactivity disorder: a pilot randomized clinical trial. AU - Tramontina,Silzá, AU - Zeni,Cristian P, AU - Ketzer,Carla R, AU - Pheula,Gabriel F, AU - Narvaez,Joana, AU - Rohde,Luis Augusto, Y1 - 2009/04/21/ PY - 2008/09/20/received PY - 2009/01/27/accepted PY - 2009/4/25/entrez PY - 2009/4/25/pubmed PY - 2009/7/23/medline SP - 756 EP - 64 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 70 IS - 5 N2 - OBJECTIVE: To assess response to treatment with aripiprazole in children and adolescents with bipolar disorder comorbid with attention-deficit/hyperactivity disorder (ADHD). METHOD: Children and adolescents were extensively assessed according to DSM-IV criteria for bipolar disorder comorbid with ADHD (n = 710). Those with this comorbidity who were acutely manic or in mixed states were randomly assigned in a 6-week double-blind, placebo-controlled trial to aripiprazole (n = 18) or placebo (n = 25). Primary outcome measures were assessed weekly and included the Young Mania Rating Scale; the Swanson, Nolan, and Pelham Scale-Version IV; and weight. Secondary outcome measures were the Clinical Global Impressions-Severity of Illness scale, the Child Mania Rating Scale-Parental Version (CMRS-P), the Children's Depression Rating Scale-Revised, the Kutcher Adolescent Depression Scale, and adverse events. The trial was conducted at the Hospital de Clínicas de Porto Alegre, Rio Grande do Sul, Brazil, from January 2005 to November 2007. RESULTS: The group receiving aripiprazole showed a significantly greater reduction in YMRS scores (P = .02, effect size [ES] = 0.80), CMRS-P scores (P = .02; ES = 0.54), and CGI-S scores (P = .04; ES = 0.28) from baseline to endpoint than the placebo group. In addition, higher rates of response (P = .02) and remission (P = .01) were found for the aripiprazole group. No significant between-group differences were found in weight, ADHD symptoms, and depressive symptoms. Adverse events significantly more frequent in the aripiprazole group were somnolence and sialorrhea. CONCLUSION: Aripiprazole was effective in reducing manic symptoms and improving global functioning without promoting severe adverse events or weight gain. No significant treatment effect in ADHD symptoms was observed. Studies are needed to assess psychopharmacologic interventions for improving ADHD symptoms in juvenile bipolar disorder comorbid with ADHD. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00116259. SN - 1555-2101 UR - https://www.unboundmedicine.com/medline/citation/19389329/Aripiprazole_in_children_and_adolescents_with_bipolar_disorder_comorbid_with_attention_deficit/hyperactivity_disorder:_a_pilot_randomized_clinical_trial_ L2 - http://www.psychiatrist.com/jcp/article/pages/2009/v70n05/v70n0517.aspx DB - PRIME DP - Unbound Medicine ER -