Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Pieter W. Troost


Contact details

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

Additional identifiers

EudraCT number number

Protocol/serial number


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.


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


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet


Psychiatric, mental disorders/illness


Treatment with risperidone

Intervention type



Not Specified

Drug names


Primary outcome measure

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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment


Trial participating centre

University Medical Center Groningen
9713 GZ

Sponsor information


National Expertise Centre for Child and Adolescent Psychiatry (Accare) (Netherlands)

Sponsor details

P.O. Box 660
9700 AR
+31 (0)50 3610973

Sponsor type




Funder type


Funder name

Janssen Cilag BV (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

The Korczak Foundation for Autism and Related Disorders (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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
2. 2006 results in
3. 2010 results in

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