Risperidone in children and adolescents with severe disruptive behaviour problems

ISRCTN	ISRCTN17120714
DOI	https://doi.org/10.1186/ISRCTN17120714
Protocol serial number	NTR294
Sponsor	National Expertise Centre for Child and Adolescent Psychiatry (Accare) (Netherlands)
Funders	Janssen Cilag BV (Netherlands), The Korczak Foundation for Autism and Related Disorders (Netherlands)

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 14/04/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Pieter W. Troost
Scientific

University Medical Center Groningen
Child and Adolescent Psychiatry Center
Hanzeplein 1
Groningen
9713 GZ
Netherlands

Study information

Primary study design	Interventional
Study design	Multicentre, randomised, double blind, placebo controlled, parallel group trial
Secondary study design	Randomised controlled trial
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.
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Psychiatric, mental disorders/illness
Intervention	Treatment with risperidone
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Risperidone
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	11/11/2003

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	5 Years
Upper age limit	17 Years
Sex	All
Target sample size at registration	36
Key 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
Key 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
Date of first enrolment	15/05/2002
Date of final enrolment	11/11/2003

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Center Groningen

Groningen
9713 GZ
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/11/2005	Yes	No
Results article	results	01/10/2006	Yes	No
Results article	results	01/12/2010	Yes	No