A Study of the Effectiveness and Safety of Two Doses of Risperidone in the Treatment of Children and Adolescents With Autistic Disorder

NCT00576732 | Completed Phase 4 Results

• 2 other identifiers: CR014740RISAUT4002
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 20

Brief Summary

The purpose of this study is to evaluate the effectiveness (change in level of irritability and related behaviors) and safety and tolerability of the administration of 2 different fixed dose levels of risperidone (an atypical antipsychotic drug) compared with placebo in children or adolescents who have autism, and to evaluate the safety and tolerability of the drug for additional 26 weeks after the initial 6-week study period.

Conditions

Autistic Disorder; Autism

Keywords

Irritability; Risperidone; Antipsychotic agent; Autism; Adolescents; Children

Outcome Measures

Primary Outcomes (1)

• Change in Aberrant Behavior Checklist Irritability (ABC-I) Subscale

  Measure of irritability symptoms of autism. Score range 0 to 45 (lower score = lesser severity).

  Baseline and 6 weeks

Secondary Outcomes (7)

• Number of Participants Who Had at Least 25% Improvement in ABC-I

  6 weeks

• Change in Clinical Global Impression Severity (CGI-S)

  Baseline and 6 weeks

• Number of Participants Who Had Clinical Global Impression Change Ratings of Much or Very Much Improved.

  6 weeks

• Change in Fasting Glucose (mg/dL) at 6 Weeks

  Baseline and 6 weeks

• Change in Insulin Resistance (IR) at 6 Weeks

  Baseline and 6 weeks

Study Arms (3)

001

EXPERIMENTAL

Risperidone low dose Risperidone oral solution 0.125 mg (if \<45 kg) or 0.175 mg (if \>=45 kg) qd or bid for 6 weeks

Drug: Risperidone low dose

002

EXPERIMENTAL

Risperidone high dose Risperidone oral solution 1.25 mg (if \<45 kg) or 1.75 mg (if \>=45 kg) qd or bid for 6 weeks

Drug: Risperidone high dose

003

PLACEBO COMPARATOR

Placebo Oral solution qd or bid for 6 weeks

Drug: Placebo

Interventions

Placebo DRUG

Oral solution qd or bid for 6 weeks

003

Risperidone high dose DRUG

Risperidone oral solution 1.25 mg (if \<45 kg) or 1.75 mg (if \>=45 kg) qd or bid for 6 weeks

002

Risperidone low dose DRUG

Risperidone oral solution 0.125 mg (if \<45 kg) or 0.175 mg (if \>=45 kg) qd or bid for 6 weeks

001

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• DSM-IV diagnosis of Autistic Disorder (299.00)
• ABC-I Subscale score of greater than or equal to 18
• CGI-S of greater than or equal to 4
• mental age \>18 months, body weight of at least 20 kg, seizure-free for at least 6 consecutive months and if on anticonvulsants must be on a dosage that has been stable for at least 4 weeks
• Medication free for 1 week before the start of the study for all psychotropic drugs, except 4 weeks for fluoxetine and at least 8 weeks for injectable medications
• Female patients must be premenarchal or sexually abstinent or, if heterosexually active, must practice an effective method of birth control.

You may not qualify if:

• History of prior or current DSM-IV psychotic disorder (e.g., schizophrenia, bipolar disorder, other psychosis), Pervasive Developmental Disorder not otherwise specified (PDD NOS), Asperger's, or Rett's
• Any history of hypersensitivity to risperidone, or its excipients in formulation, or other known drug allergy
• Patients who received risperidone within 3 months before screening (except p.r.n. use)
• Patients who did not demonstrate sufficient clinical response to an adequate trial of risperidone treatment in the past (an adequate trial is defined as a period of at least 4 weeks at an adequate dose)
• Neurologic disorder (e.g., Neuroleptic Malignant Syndrome, seizure disorders that are unstable, seizure activity within the past 6 months)
• History of alcohol or substance dependence within 3 months of screening
• Female subject who is pregnant (positive beta-HCG) or breast feeding
• Patients with existing moderate or severe EPS or history of tardive dyskinesia
• Patients who have received an experimental drug or used an experimental medical device within 3 months before the planned start of treatment.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (20)

Unknown Facility

Dothan, Alabama, United States

Location

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Sacramento, California, United States

Location

Unknown Facility

Santa Ana, California, United States

Location

Unknown Facility

Boca Raton, Florida, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Smyrna, Georgia, United States

Location

Unknown Facility

Hoffman Estates, Illinois, United States

Location

Unknown Facility

Naperville, Illinois, United States

Location

Unknown Facility

Lake Charles, Louisiana, United States

Location

Unknown Facility

Manhasset, New York, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Staten Island, New York, United States

Location

Unknown Facility

The Bronx, New York, United States

Location

Unknown Facility

Columbus, Ohio, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Fairfax, Virginia, United States

Location

Unknown Facility

Portsmouth, Virginia, United States

Location

Related Publications (3)

• Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.

  PMID: 37811711 DERIVED

• Kent JM, Hough D, Singh J, Karcher K, Pandina G. An open-label extension study of the safety and efficacy of risperidone in children and adolescents with autistic disorder. J Child Adolesc Psychopharmacol. 2013 Dec;23(10):676-86. doi: 10.1089/cap.2012.0058.

  PMID: 24350813 DERIVED

• Kent JM, Kushner S, Ning X, Karcher K, Ness S, Aman M, Singh J, Hough D. Risperidone dosing in children and adolescents with autistic disorder: a double-blind, placebo-controlled study. J Autism Dev Disord. 2013 Aug;43(8):1773-83. doi: 10.1007/s10803-012-1723-5.

  PMID: 23212807 DERIVED

Related Links

• A Study of the Effectiveness and Safety of Two Doses of Risperidone in the Treatment of Children and Adolescents With Autistic Disorder

MeSH Terms

Conditions

Autistic Disorder

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Clinical Leader
• Organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

609 730 2317

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2007
• First Posted: December 19, 2007
• Study Start: December 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: March 1, 2010
• Last Updated: May 9, 2014
• Results First Posted: September 28, 2010

Record last verified: 2014-04

Locations

US (20)