Risperidone in children and adolescents with severe disruptive behaviour problems
| ISRCTN | ISRCTN17120714 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17120714 |
| Secondary identifying numbers | NTR294 |
- 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
Scientific
University Medical Center Groningen
Child and Adolescent Psychiatry Center
Hanzeplein 1
Groningen
9713 GZ
Netherlands
Study information
| Study design | Multicentre, randomised, double blind, placebo controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 15/05/2002 |
| Completion date | 11/11/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | 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
9713 GZ
Netherlands
Sponsor information
National Expertise Centre for Child and Adolescent Psychiatry (Accare) (Netherlands)
University/education
University/education
P.O. Box 660
Groningen
9700 AR
Netherlands
| Phone | +31 (0)50 3610973 |
|---|---|
| info@accare.nl | |
| Website | http://www.accare.nl/ |
"ROR" |
https://ror.org/02h4pw461 |
Funders
Funder type
Industry
Janssen Cilag BV (Netherlands)
No information available
The Korczak Foundation for Autism and Related Disorders (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | 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 |
