Phase 4 N=96 Randomized Triple-blind Treatment

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

Autistic Disorder · Autism

Bottom Line

View on ClinicalTrials.gov: NCT00576732 ↗

Enrolled (actual)

Serious AEs

1.1%

Results posted

Sep 2010

Primary outcome: Primary: Change in Aberrant Behavior Checklist Irritability (ABC-I) Subscale — -3.5; -7.4; -12.4 units on a scale — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Placebo (Drug); Risperidone high dose (Drug); Risperidone low dose (Drug)
Age: Pediatric · 5+ yrs
Sex: All
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Aberrant Behavior Checklist Irritability (ABC-I) Subscale	-3.5; -7.4; -12.4	<0.001 sig
SECONDARY Number of Participants Who Had at Least 25% Improvement in ABC-I	14; 15; 24	0.004 sig
SECONDARY Change in Clinical Global Impression Severity (CGI-S)	-0.3; -0.4; -1.0	<0.001 sig
SECONDARY Number of Participants Who Had Clinical Global Impression Change Ratings of Much or Very Much Improved.	5; 5; 19	<0.001 sig
SECONDARY Change in Fasting Glucose (mg/dL) at 6 Weeks	-0.4; -0.1; -0.3	—
SECONDARY Change in Insulin Resistance (IR) at 6 Weeks	0.36; -0.10; 0.45	—
SECONDARY Change in Fasting Glucose (mg/dL) at 6 Months	4.0; 3.5; 2.3	—
SECONDARY Change in Insulin Resistance (IR) at 6 Months	0.09; 0.36; 0.75	—

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.

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00576732). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.