Condition category
Mental and Behavioural Disorders
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
14/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Pieter W. Troost

ORCID ID

Contact details

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

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 measures

Protocol I: the Irritability Scale of the Aberrant Behaviour 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 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

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, 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

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

http://www.accare.nl/

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes