No registrations found.
ID
Source
Brief title
Health condition
1. Patients continuing on risperidone;
2. Patients randomized to placebo.
Sponsors and support
Hanzeplein 1,
9713 GZ Groningen,
the Netherlands
Study medications were donated by Janssen Cilag BV.
Intervention
Outcome measures
Primary outcome
Protocol I: The Irritability Scale of the Aberrant Behavior Checklist (ABC) and the Clinician’s Global Improvement score.
Protocol II: The proportion of patients in each treatment group (i.e., active, placebo) who relapse during the randomization phase.
Secondary outcome
1. CYBOCS;
2. The other subscales of the ABC;
3. Children Social Behavior Questionnaire;
4. Amsterdam Neuropsychological Tasks;
5. Adverse events as measured by a a 32-item questionnaire;
6. Simpson-Angus Scale;
7. Abnormal Involuntary Movement Scale.
Background summary
This study indicates the effectiveness of risperidone over a period of several months regarding reducing disruptive behavior in about half of the children with autism spectrum disorders.
The results provide a rationale for the continuing use of risperidone beyond 6 months, although considerable weight gain can limit the use of this agent.
Study objective
Protocol I:
1. Risperidone will be effective in reducing impulsive aggression, agitation, self-injurious behavior and troublesome repetitive behavior associated with autism and related disorders;
2. Risperidone will result in sedation (transient) and weight gain.
Protocol II:
1. Patients continued on risperidone will be significantly less likely to experience exacerbation of symptoms of irritability, aggression, agitation, and stereotypy than those randomized to placebo, as measured by the Aberrant Behavior Checklist (ABC) and the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS).
2. Patients continued on risperidone would show superior adjustment and functioning at the end of the trial, as evidenced by lower Clinical Global Impression ratings, when compared to patients randomized to placebo.
Study design
N/A
Intervention
Treament with risperidone.
Hanzeplein 1
Pieter W. Troost
Hanzeplein 1
Groningen 9713 GZ
The Netherlands
+31 (0)50 3681100
p.troost@accare.nl
Hanzeplein 1
Pieter W. Troost
Hanzeplein 1
Groningen 9713 GZ
The Netherlands
+31 (0)50 3681100
p.troost@accare.nl
Inclusion criteria
1. Age between 5 and 17 years 2 months;
2. Body weight > 15 kg;
3. DSM-IV TR diagnosis of Autistic Spectrum Disorder (Autistic disorder or Asperger syndrome or PDDNOS (established by clinical assessment, corroborated by algorithm cutoff scores on the Autism Diagnostic Interview);
4. Inpatients or outpatients;
5. Medication-free for at least two weeks for all psychotropic medications (four weeks for fluoxetine or depot neuroleptics). In the case of ADHD-comorbidity ritalin can be continued, provided that no changes in dose during the study will occur;
6. Anticonvulsants used for the treatment of a seizure disorder will be permitted if the dosage has been stable for 4 weeks and the patient is seizure free for at least 6months;
7. Clinical Global Impression (CGI) severity score of at least 4; and a score of 18 or greater on the Irritability Scale of the Aberrant Behavior Checklist;
8. A mental age of at least 18 months as measured by the age –appropriate form of the Wechsler Intelligence test (whenever possible) or by the revised Leiter or by the Mullen.
Exclusion criteria
1. Females with a positive Beta HCG pregnancy test;
2. Evidence of hypersensitivity to risperidone (defined as allergic response [e.g., skin rash] or potentially serious adverse effect [e.g., significant tachycardia];
3. Past history of neuroleptic malignant syndrome;
4. DSM-IV TR diagnosis of a Pervasive Developmental Disorder other than Autistic Disorder, PDD-NOS, Asperger’s Disorder (e.g., Rett’s Disorder, Childhood Disintegrative Disorder), schizophrenia, another psychotic disorder, substance abuse;
5. A significant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, or unstable seizure disorder identified by history, physical examination or laboratory tests.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL256 |
| NTR-old | NTR294 |
| Other | : N/A |
| ISRCTN | ISRCTN17120714 |