1. Patients continuing on risperidone
Conditions
Interventions
Treament with risperidone.
Sponsors
Accare, division University Center for Child and Adolescent Psychiatry
Hanzeplein 1,
9713 GZ Groningen,
the Netherlands
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactPieter W. Troost
University Medical Center Groningen (UMCG), Child and Adolescent Psychiatry Center, Hanzeplein 1
Outcome results
None listed