Autistic disorder MedDRA version: 17.1 Level: LLT Classification code 10003808 Term: Autistic disorder System Organ Class: 100000004852
Conditions
Interventions
Trade Name: RISPERDAL
Pharmaceutical Form: Oral solution
INN or Proposed INN: RISPERIDONE
Other descriptive name: RISPERIDONE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: up t
Sponsors
Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? yes Number of subjects for this age range: 96 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Not applicable;Primary end point(s): Change in Aberrant Behavior Checklist Irritability (ABC-I) subscale;Timepoint(s) of evaluation of this end point: Baseline and 6 weeks;Main Objective: 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number of participants who had at least 25% improvement in ABC-I - Change in Clinical Global Impression Severity (CGI-S) - Number of participants who had Clinical Global Impression Change ratings of much or very much improved. - Change in Fasting Glucose (mg/dL) at 6 weeks - Change in Insulin Resistance (IR) at 6 weeks - Change in Fasting Glucose (mg/dL) at 6 months - Change in Insulin Resistance (IR) at 6 months;Timepoint(s) of evaluation of this end point: Baseline and/or 6 weeks | — |
Countries
United States
Contacts
Public ContactClinical Registry Group-JB BV
Janssen Research and Development
Outcome results
None listed