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

Conditions: Autistic disorder
MedDRA version: 17.1Level: LLTClassification code 10003808Term: Autistic disorderSystem Organ Class: 100000004852
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2015-001220-31-Outside-EU/EEA

Lead Sponsor: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 96

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

- 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.