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A placebo-controlled, fixed-dose study of aripiprazole in children and adolescents with irritability associated with autistic disorder.
J Am Acad Child Adolesc Psychiatry. 2009 Nov; 48(11):1110-1119.JA

Abstract

OBJECTIVE

To evaluate the short-term efficacy and safety of aripiprazole in the treatment of irritability in children and adolescents with autistic disorder.

METHOD

Two hundred eighteen children and adolescents (aged 6-17 years) with a diagnosis of autistic disorder, and with behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these symptoms, were randomized 1:1:1:1 to aripiprazole (5, 10, or 15 mg/day) or placebo in this 8-week double-blind, randomized, placebo-controlled, parallel-group study. Efficacy was evaluated using the caregiver-rated Aberrant Behavior Checklist Irritability subscale (primary efficacy measure) and the clinician-rated Clinical Global Impressions-Improvement score. Safety and tolerability were also assessed.

RESULTS

At week 8, all aripiprazole doses produced significantly greater improvement than placebo in mean Aberrant Behavior Checklist Irritability subscale scores (5 mg/day, -12.4; 10 mg/day, -13.2; 15 mg/day, -14.4; versus placebo, -8.4; all p < .05). All aripiprazole doses demonstrated significantly greater improvements in mean Clinical Global Impressions-Improvement score than placebo at week 8. Discontinuation rates due to adverse events were as follows: placebo 7.7%, aripiprazole 5 mg/day 9.4%, 10 mg/day 13.6%, and 15 mg/day 7.4%. The most common adverse event leading to discontinuation was sedation. There were two serious adverse events: presyncope (5 mg/day) and aggression (10 mg/day). At week 8, mean weight change (last observation carried forward) was as follows: placebo +0.3 kg, aripiprazole 5 mg/day +1.3 kg, 10 mg/day +1.3 kg, and 15 mg/day +1.5 kg; all p < .05 versus placebo.

CONCLUSIONS

Aripiprazole was efficacious and generally safe and well tolerated in the treatment of children and adolescents with irritability associated with autistic disorder.

Authors+Show Affiliations

Drs. Marcus, Owen, Kamen, and Manos are with Bristol-Myers Squibb; Drs. McQuade and Carson are with Otsuka Pharmaceutical Development & Commercialization and Dr. Aman is with Ohio State University.Drs. Marcus, Owen, Kamen, and Manos are with Bristol-Myers Squibb; Drs. McQuade and Carson are with Otsuka Pharmaceutical Development & Commercialization and Dr. Aman is with Ohio State University. Electronic address: randall.owen@bms.com.Drs. Marcus, Owen, Kamen, and Manos are with Bristol-Myers Squibb; Drs. McQuade and Carson are with Otsuka Pharmaceutical Development & Commercialization and Dr. Aman is with Ohio State University.Drs. Marcus, Owen, Kamen, and Manos are with Bristol-Myers Squibb; Drs. McQuade and Carson are with Otsuka Pharmaceutical Development & Commercialization and Dr. Aman is with Ohio State University.Drs. Marcus, Owen, Kamen, and Manos are with Bristol-Myers Squibb; Drs. McQuade and Carson are with Otsuka Pharmaceutical Development & Commercialization and Dr. Aman is with Ohio State University.Drs. Marcus, Owen, Kamen, and Manos are with Bristol-Myers Squibb; Drs. McQuade and Carson are with Otsuka Pharmaceutical Development & Commercialization and Dr. Aman is with Ohio State University.Drs. Marcus, Owen, Kamen, and Manos are with Bristol-Myers Squibb; Drs. McQuade and Carson are with Otsuka Pharmaceutical Development & Commercialization and Dr. Aman is with Ohio State University.

Pub Type(s)

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

Language

eng

PubMed ID

19797985

Citation

Marcus, Ronald N., et al. "A Placebo-controlled, Fixed-dose Study of Aripiprazole in Children and Adolescents With Irritability Associated With Autistic Disorder." Journal of the American Academy of Child and Adolescent Psychiatry, vol. 48, no. 11, 2009, pp. 1110-1119.
Marcus RN, Owen R, Kamen L, et al. A placebo-controlled, fixed-dose study of aripiprazole in children and adolescents with irritability associated with autistic disorder. J Am Acad Child Adolesc Psychiatry. 2009;48(11):1110-1119.
Marcus, R. N., Owen, R., Kamen, L., Manos, G., McQuade, R. D., Carson, W. H., & Aman, M. G. (2009). A placebo-controlled, fixed-dose study of aripiprazole in children and adolescents with irritability associated with autistic disorder. Journal of the American Academy of Child and Adolescent Psychiatry, 48(11), 1110-1119. https://doi.org/10.1097/CHI.0b013e3181b76658
Marcus RN, et al. A Placebo-controlled, Fixed-dose Study of Aripiprazole in Children and Adolescents With Irritability Associated With Autistic Disorder. J Am Acad Child Adolesc Psychiatry. 2009;48(11):1110-1119. PubMed PMID: 19797985.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A placebo-controlled, fixed-dose study of aripiprazole in children and adolescents with irritability associated with autistic disorder. AU - Marcus,Ronald N, AU - Owen,Randall, AU - Kamen,Lisa, AU - Manos,George, AU - McQuade,Robert D, AU - Carson,William H, AU - Aman,Michael G, PY - 2009/10/3/entrez PY - 2009/10/3/pubmed PY - 2010/2/18/medline SP - 1110 EP - 1119 JF - Journal of the American Academy of Child and Adolescent Psychiatry JO - J Am Acad Child Adolesc Psychiatry VL - 48 IS - 11 N2 - OBJECTIVE: To evaluate the short-term efficacy and safety of aripiprazole in the treatment of irritability in children and adolescents with autistic disorder. METHOD: Two hundred eighteen children and adolescents (aged 6-17 years) with a diagnosis of autistic disorder, and with behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these symptoms, were randomized 1:1:1:1 to aripiprazole (5, 10, or 15 mg/day) or placebo in this 8-week double-blind, randomized, placebo-controlled, parallel-group study. Efficacy was evaluated using the caregiver-rated Aberrant Behavior Checklist Irritability subscale (primary efficacy measure) and the clinician-rated Clinical Global Impressions-Improvement score. Safety and tolerability were also assessed. RESULTS: At week 8, all aripiprazole doses produced significantly greater improvement than placebo in mean Aberrant Behavior Checklist Irritability subscale scores (5 mg/day, -12.4; 10 mg/day, -13.2; 15 mg/day, -14.4; versus placebo, -8.4; all p < .05). All aripiprazole doses demonstrated significantly greater improvements in mean Clinical Global Impressions-Improvement score than placebo at week 8. Discontinuation rates due to adverse events were as follows: placebo 7.7%, aripiprazole 5 mg/day 9.4%, 10 mg/day 13.6%, and 15 mg/day 7.4%. The most common adverse event leading to discontinuation was sedation. There were two serious adverse events: presyncope (5 mg/day) and aggression (10 mg/day). At week 8, mean weight change (last observation carried forward) was as follows: placebo +0.3 kg, aripiprazole 5 mg/day +1.3 kg, 10 mg/day +1.3 kg, and 15 mg/day +1.5 kg; all p < .05 versus placebo. CONCLUSIONS: Aripiprazole was efficacious and generally safe and well tolerated in the treatment of children and adolescents with irritability associated with autistic disorder. SN - 1527-5418 UR - https://www.unboundmedicine.com/medline/citation/19797985/A_placebo_controlled_fixed_dose_study_of_aripiprazole_in_children_and_adolescents_with_irritability_associated_with_autistic_disorder_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0890-8567(09)60259-8 DB - PRIME DP - Unbound Medicine ER -