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Paliperidone for irritability in adolescents and young adults with autistic disorder.
Psychopharmacology (Berl). 2012 Sep; 223(2):237-45.P

Abstract

RATIONALE

Individuals with autistic disorder (autism) frequently exhibit significant irritability marked by severe tantrums, aggression, and self-injury. Despite advances in the treatment of this symptom domain in autism, there remains an ongoing need for more effective and better tolerated pharmacotherapies.

OBJECTIVES

The aim of this study is to determine the effectiveness and tolerability of paliperidone for irritability in autism.

METHODS

This is a prospective, 8-week open-label study of paliperidone in 25 adolescents and young adults with autism. Primary outcome measures included the Clinical Global Impressions-Improvement (CGI-I) Scale and the Irritability subscale of the Aberrant Behavior Checklist (ABC-I). Concomitant medications (except antipsychotics) were permitted if dosages were stable for ≥2 months.

RESULTS

Twenty-one (84 %) of 25 subjects ages 12-21 years (mean 15.3 years) responded to paliperidone, based on a CGI-I Scale score of 1 or 2 (very much or much improved) and ≥25 % improvement on the ABC-I. The mean final dosage of paliperidone was 7.1 mg/day (range 3-12 mg/day). Two subjects discontinued paliperidone prior to study completion (moderate sedation, n = 1; nonresponse, n = 1). Mild-to-moderate extrapyramidal symptoms were recorded in four subjects. A mean weight gain of 2.2 ± 2.6 kg (range -3.6 to +7.9 kg) was recorded. Mean age- and sex-normed body mass index increased from 23.6 to 24.2 (p ≤ 0.001). Mean serum prolactin increased from 5.3 to 41.4 ng/mL (p ≤ 0.0001).

CONCLUSIONS

Paliperidone treatment was associated with significant improvement in irritability and was generally well tolerated. Larger scale, placebo-controlled studies are needed to elucidate the efficacy and tolerability of paliperidone in this population.

Links

Publisher Full Text

Authors+Show Affiliations

Stigler KA
Section of Child and Adolescent Psychiatry, Department of Psychiatry, Indiana University School of Medicine, Christian Sarkine Autism Treatment Center, James Whitcomb Riley Hospital for Children, 705 Riley Hospital Drive, Indianapolis, IN 46202-5200, USA. kstigler@iupui.edu
Mullett JE
No affiliation info available
Erickson CA
No affiliation info available
Posey DJ
No affiliation info available
McDougle CJ
No affiliation info available

MeSH

AdolescentAntipsychotic AgentsAutistic DisorderChildDiagnostic and Statistical Manual of Mental DisordersDrug Administration ScheduleFemaleHumansIrritable MoodIsoxazolesMalePaliperidone PalmitatePilot ProjectsProspective StudiesPsychiatric Status Rating ScalesPyrimidinesSeverity of Illness IndexTreatment OutcomeYoung Adult

Pub Type(s)

Clinical Trial
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22549762

Clinical Trial Links

Study of Paliperidone ER in Adolescents and Young Adults With Autism

Citation

Stigler, Kimberly A., et al. "Paliperidone for Irritability in Adolescents and Young Adults With Autistic Disorder." Psychopharmacology, vol. 223, no. 2, 2012, pp. 237-45.
Stigler KA, Mullett JE, Erickson CA, et al. Paliperidone for irritability in adolescents and young adults with autistic disorder. Psychopharmacology (Berl). 2012;223(2):237-45.
Stigler, K. A., Mullett, J. E., Erickson, C. A., Posey, D. J., & McDougle, C. J. (2012). Paliperidone for irritability in adolescents and young adults with autistic disorder. Psychopharmacology, 223(2), 237-45. https://doi.org/10.1007/s00213-012-2711-3
Stigler KA, et al. Paliperidone for Irritability in Adolescents and Young Adults With Autistic Disorder. Psychopharmacology (Berl). 2012;223(2):237-45. PubMed PMID: 22549762.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Paliperidone for irritability in adolescents and young adults with autistic disorder. AU - Stigler,Kimberly A, AU - Mullett,Jennifer E, AU - Erickson,Craig A, AU - Posey,David J, AU - McDougle,Christopher J, Y1 - 2012/05/03/ PY - 2011/09/03/received PY - 2012/03/28/accepted PY - 2012/5/3/entrez PY - 2012/5/3/pubmed PY - 2013/1/15/medline SP - 237 EP - 45 JF - Psychopharmacology JO - Psychopharmacology (Berl) VL - 223 IS - 2 N2 - RATIONALE: Individuals with autistic disorder (autism) frequently exhibit significant irritability marked by severe tantrums, aggression, and self-injury. Despite advances in the treatment of this symptom domain in autism, there remains an ongoing need for more effective and better tolerated pharmacotherapies. OBJECTIVES: The aim of this study is to determine the effectiveness and tolerability of paliperidone for irritability in autism. METHODS: This is a prospective, 8-week open-label study of paliperidone in 25 adolescents and young adults with autism. Primary outcome measures included the Clinical Global Impressions-Improvement (CGI-I) Scale and the Irritability subscale of the Aberrant Behavior Checklist (ABC-I). Concomitant medications (except antipsychotics) were permitted if dosages were stable for ≥2 months. RESULTS: Twenty-one (84 %) of 25 subjects ages 12-21 years (mean 15.3 years) responded to paliperidone, based on a CGI-I Scale score of 1 or 2 (very much or much improved) and ≥25 % improvement on the ABC-I. The mean final dosage of paliperidone was 7.1 mg/day (range 3-12 mg/day). Two subjects discontinued paliperidone prior to study completion (moderate sedation, n = 1; nonresponse, n = 1). Mild-to-moderate extrapyramidal symptoms were recorded in four subjects. A mean weight gain of 2.2 ± 2.6 kg (range -3.6 to +7.9 kg) was recorded. Mean age- and sex-normed body mass index increased from 23.6 to 24.2 (p ≤ 0.001). Mean serum prolactin increased from 5.3 to 41.4 ng/mL (p ≤ 0.0001). CONCLUSIONS: Paliperidone treatment was associated with significant improvement in irritability and was generally well tolerated. Larger scale, placebo-controlled studies are needed to elucidate the efficacy and tolerability of paliperidone in this population. SN - 1432-2072 UR - https://www.unboundmedicine.com/medline/citation/22549762/Paliperidone_for_irritability_in_adolescents_and_young_adults_with_autistic_disorder_ L2 - https://dx.doi.org/10.1007/s00213-012-2711-3 DB - PRIME DP - Unbound Medicine ER -