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

Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Autistic Disorder; Autism

Intervention: Placebo (Drug); Risperidone high dose (Drug); Risperidone low dose (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

Clinical Details

Official title: Risperidone in the Treatment of Children and Adolescents With Autistic Disorder: A Double-Blind, Placebo-Controlled Study of Efficacy and Safety, Followed by an Open-Label Extension Study of Safety

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change in Aberrant Behavior Checklist Irritability (ABC-I) Subscale

Secondary outcome:

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

Detailed description: Autistic Disorder is a condition that develops early in childhood and persists throughout life. Seventy-five percent of children and adolescents with autistic disorder have irritability symptoms such as aggression towards others, deliberate self-injurious behavior, temper tantrums, and quickly changing moods. These symptoms affect their daily functioning such as school performance, interactions with family members and compliance to treatment. Risperidone is an atypical antipsychotic agent that has been recently approved for the treatment of irritability associated with Autistic Disorder in children and adolescents aged 5 to 16 years. The approved dose range is 0. 5-3 mg per day. The aim of this study is to evaluate the effectiveness (change in level of irritability and related behaviors) of a lower dose (0. 125 mg or 0. 175 mg risperidone per day depending on body weight). The study will include three treatment groups. A placebo group, a low dose risperidone group and a higher dose risperidone group (1. 25 mg or 1. 75mg per day depending on body weight). This phase of the study will be 6 weeks. During the study, neither investigators nor the patients will be told which treatment the patient received. This is called "double blind". The placebo treatment is not expected to be effective. The higher dose group is expected to be effective. At the end of the study, data from the lower dose group will be compared to the placebo group to see if it is effective. Another aim of this study is to evaluate the safety and tolerability of risperidone. At the end of the 6-week double-blind period, patients may enter a 6-month open-label period during which all patients will receive risperidone. During this phase of the study, the doses can be adjusted to a maximum of 1. 25 mg or 1. 75mg per day depending on body weight. Both investigator and the patient will know what dose the patient is taking. About 93 patients will be randomized. The study will be conducted by investigators from about 15 clinics. Assessments of effectiveness include the Aberrant Behavior Checklist (ABC) subscales including the irritability subscale (ABC-I), the Clinical Global Impression of Change (CGI C); the Clinical Global Impression of Severity (CGI-S); the response rate, and the Compulsions Subscale of the Children's Yale-Brown Obsessive Compulsive Scale (CY BOCS). Safety evaluations include monitoring of adverse events, physical examinations, clinical laboratory tests, nighttime sleep quality and daytime drowsiness, and extrapyramidal symptoms (EPS) as assessed using the Abnormal Involuntary Movement Scale (AIMS), the Barnes Akathisia Rating Scale (BARS) and the Simpson-Angus Scale (SAS). Venous blood samples will be collected for the determination of plasma concentrations of risperidone and 9-hydroxyrisperidone. The study hypotheses are that the higher dose level of risperidone is significantly superior to placebo as measured by change from baseline on the ABC-I Subscale score at end point (Week 6 or early withdrawal) and that the lower dose level of risperidone is significantly superior to placebo as measured by change from baseline on the ABC-I Subscale score at end point (Week 6 or early withdrawal). Double-blind phase: Risperidone oral solutions taken once daily. Depending on body weight patients take 1. 25 mL or 1. 75 mL of either a 0. 1 mg/mL or a 1. 0 mg/mL risperidone solution or matching placebo, for 6 weeks. Open-label phase: Medication can be taken once or twice a day. Starting from 0. 125mg or 0. 175mg per day, drug levels are titrated over 2 weeks to a maximum dose level of 1. 25 mg risperidone/day or 1. 75 mg /day depending on body weight, for 26 weeks.

Eligibility

Minimum age: 5 Years. Maximum age: 17 Years. Gender(s): Both.

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.

Locations and Contacts

Dothan, Alabama, United States

Phoenix, Arizona, United States

Sacramento, California, United States

Santa Ana, California, United States

Boca Raton, Florida, United States

Miami, Florida, United States

Smyrna, Georgia, United States

Hoffman Estates, Illinois, United States

Naperville, Illinois, United States

Lake Charles, Louisiana, United States

Bronx, New York, United States

Manhasset, New York, United States

New York, New York, United States

Staten Island, New York, United States

Columbus, Ohio, United States

Oklahoma City, Oklahoma, United States

Philadelphia, Pennsylvania, United States

Houston, Texas, United States

Fairfax, Virginia, United States

Portsmouth, Virginia, United States

Additional Information

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

Starting date: December 2007
Last updated: April 24, 2014

Page last updated: August 23, 2015

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