Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR294
Study information
Scientific title
Protocol I: An Open Label Study of Risperidone in Children and Adolescents with Autism and Other Pervasive Disorders.
Protocol II: An Open Label Continuation Study of Risperidone in Children and Adolescents with Autism and Other Pervasive Disorders Followed By a Double-Blind, Placebo-Controlled Discontinuation Study.
Acronym
Study hypothesis
Protocol I:
1. Risperidone will be effective in reducing impulsive aggression, agitation, self-injurious behaviour and troublesome repetitive behaviour 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 randomised to placebo, as measured by the Aberrant Behaviour 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 randomised to placebo
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Multicentre, randomised, double blind, placebo controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Psychiatric, mental disorders/illness
Intervention
Treatment with risperidone
Intervention type
Drug
Phase
Not Specified
Drug names
Risperidone
Primary outcome measure
Protocol I: the Irritability Scale of the Aberrant Behaviour Checklist (ABC) and the Clinicians Global Improvement score
Protocol II: the proportion of patients in each treatment group (i.e., active, placebo) who relapse during the randomisation phase
Secondary outcome measures
1. Children's Yale-Brown Obsessive Compulsive Scale (CYBOCS)
2. The other subscales of the ABC
3. Children Social Behavior Questionnaire
4. Amsterdam Neuropsychological Tasks
5. Adverse events as measured by a 32-item questionnaire
6. Simpson-Angus Scale
7. Abnormal Involuntary Movement Scale
Overall trial start date
15/05/2002
Overall trial end date
11/11/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age between 5 and 17 years 2 months
2. Body weight greater than 15 kg
3. Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV TR) diagnosis of Autistic Spectrum Disorder (Autistic disorder or Asperger syndrome or Pervasive Developmental Disorder, Not Otherwise Specified [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-co morbidity 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 6 months
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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
36
Participant exclusion criteria
1. Females with a positive Beta Human Chorionic Gonadotropin (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, Aspergers Disorder (e.g., Retts 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
Recruitment start date
15/05/2002
Recruitment end date
11/11/2003
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Groningen
Groningen
9713 GZ
Netherlands
Sponsor information
Organisation
National Expertise Centre for Child and Adolescent Psychiatry (Accare) (Netherlands)
Sponsor details
P.O. Box 660
Groningen
9700 AR
Netherlands
+31 (0)50 3610973
info@accare.nl
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Janssen Cilag BV (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Korczak Foundation for Autism and Related Disorders (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16239862
2. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17069545
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21186965
Publication citations
-
Results
Troost PW, Lahuis BE, Steenhuis MP, Ketelaars CE, Buitelaar JK, van Engeland H, Scahill L, Minderaa RB, Hoekstra PJ, Long-term effects of risperidone in children with autism spectrum disorders: a placebo discontinuation study., J Am Acad Child Adolesc Psychiatry, 2005, 44, 11, 1137-1144, doi: 10.1097/01.chi.0000177055.11229.76.
-
Results
Troost PW, Althaus M, Lahuis BE, Buitelaar JK, Minderaa RB, Hoekstra PJ, Neuropsychological effects of risperidone in children with pervasive developmental disorders: a blinded discontinuation study., J Child Adolesc Psychopharmacol, 2006, 16, 5, 561-573, doi: 10.1089/cap.2006.16.561.
-
Results
Hoekstra PJ, Troost PW, Lahuis BE, Mulder H, Mulder EJ, Franke B, Buitelaar JK, Anderson GM, Scahill L, Minderaa RB, Risperidone-induced weight gain in referred children with autism spectrum disorders is associated with a common polymorphism in the 5-hydroxytryptamine 2C receptor gene., J Child Adolesc Psychopharmacol, 2010, 20, 6, 473-477, doi: 10.1089/cap.2009.0071.