Condition category
Mental and Behavioural Disorders
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
26/02/2007
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 Centre Groningen (UMCG)
Child and Adolescent Psychiatry Centre
Hanzeplein 1
Groningen
9713 GZ
Netherlands
+31 (0)50 368 1100
p.troost@accare.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

AAAS

Study hypothesis

The aim of this study was to examine the tolerability and effectiveness of atomoxetine on Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms and autistic features in children with pervasive developmental disorders.

Hypothesis:
Atomoxetine will be effective in reducing symptoms of inattention and overactivity in children and adolescents with Autism Spectrum Disorder (ASD).

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Open label clinical trial

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Attention Deficit Hyperactivity Disorder (ADHD), Pervasive Developmental Disorders

Intervention

Treatment with open label atomoxetine for ten weeks.

Intervention type

Drug

Phase

Not Specified

Drug names

Atomoxetine

Primary outcome measures

Change in the ADHD-Rating Scale-I (ADHDRS).

Secondary outcome measures

1. Clinical Global Impression Scale of improvement with regard to ADHD symptoms (CGI-ADHD-I)
2. The short form of the Conners’ Parent Rating Scale-Revised (CPRS-R)
3. The short form of the Conners’ Teacher Rating Scale-Revised (CTRS-R)
4. The Aberrant Behavior Checklist (ABC)
5. The Children’s Social Behaviour Questionnaire (CSBQ)
6. Nisonger Child Behavior Rating Form
7. Children's Yale-Brown Obsessive Compulsive Scale
8. Child Health and Illness Profile-CE
9. Cognitive Battery:
a. Wechsler Intelligence Scale for Children-III (WISC-III) Mazes
b. WISC-III Working Memory
10. Vineland Maladaptive Subscale
11. Safety measures:
a. routine lab
b. physical examination
c. Electrocardiogram (ECG)
d. open-ended questioning for adverse events

Overall trial start date

25/02/2004

Overall trial end date

20/10/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males and females between the ages of at least six years of age and not more than 17 years of age at visit one
2. ASD (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition [DSM-IV TR] diagnosis of autistic disorder or Asperger’s disorder or Pervasive Developmental Disorder (PDD) not otherwise specified, established by clinical assessment and corroborated by Autism Diagnostic Interview scores
3. Patients must score greater than four on the Clinical Global Impressions (CGI)-severity scale with regard to ADHD symptoms and score at least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the Attention-Deficit/Hyperactivity Rating Scale four (ADHDRS-IV) Parent Version
4. Outpatients
5. Medication-free for at least two weeks for all psychotropic medications (four weeks for fluoxetine or neuroleptics)
6. Intelligence Quotient (IQ) of at least 70
7. Laboratory results, including serum chemistries, hematology, and urinalysis, show no significant abnormalities and there is no clinical information that, in the judgment of a physician, should preclude a patient’s participation at study entry
8. Patients and parents (legal representative) have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venapunctures, and examinations required by the protocol. Patients must also be able to swallow capsules (study drug)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

12

Participant exclusion criteria

1. Patients who weigh less than 20 kg at study entry
2. Females with a positive beta-Human Chorionic Gonadotropin (HCG) pregnancy test
3. Patients with a history of severe allergies to more than one class of medications or multiple adverse drug reactions
4. DSM-IV TR diagnosis of a PDD other than Autistic Disorder, PDD- Not Otherwise Specified, 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 seizure disorder identified by history, physical examination, or laboratory tests

Recruitment start date

25/02/2004

Recruitment end date

20/10/2004

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Groningen (UMCG)
Groningen
9713 GZ
Netherlands

Sponsor information

Organisation

Accare (The Netherlands)

Sponsor details

Division University Centre for Child and Adolescent Psychiatry
P.O. Box 660
Groningen
9700 AR
Netherlands
+31 (0)50 361 0973
info@accare.nl

Sponsor type

Hospital/treatment centre

Website

http://www.accare.nl/

Funders

Funder type

Industry

Funder name

Eli Lilly Holdings Limited (UK)

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

Publication citations

Additional files

Editorial Notes