Atomoxetine for Attention-deficit hyperActivity disorder Symptoms in children with pervasive developmental disorders: a pilot study
| ISRCTN | ISRCTN25479460 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25479460 |
| Secondary identifying numbers | NL407 (NTR447) |
- Submission date
- 26/02/2007
- Registration date
- 26/02/2007
- Last edited
- 26/03/2021
- 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 Centre Groningen (UMCG)
Child and Adolescent Psychiatry Centre
Hanzeplein 1
Groningen
9713 GZ
Netherlands
| Phone | +31 (0)50 368 1100 |
|---|---|
| p.troost@accare.nl |
Study information
| Study design | Open label clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Single-centre |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Atomoxetine for Attention-deficit hyperActivity disorder Symptoms in children with pervasive developmental disorders: a pilot study |
| Study acronym | AAAS |
| Study objectives | 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(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Attention Deficit Hyperactivity Disorder (ADHD), Pervasive Developmental Disorders |
| Intervention | Treatment with open label atomoxetine for ten weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Atomoxetine |
| Primary outcome measure | 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 Childrens 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 study start date | 25/02/2004 |
| Completion date | 20/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | 12 |
| Total final enrolment | 12 |
| Key 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 Aspergers 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 patients 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) |
| Key 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, 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 seizure disorder identified by history, physical examination, or laboratory tests |
| Date of first enrolment | 25/02/2004 |
| Date of final enrolment | 20/10/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Groningen (UMCG)
Groningen
9713 GZ
Netherlands
9713 GZ
Netherlands
Sponsor information
Accare (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Division University Centre for Child and Adolescent Psychiatry
P.O. Box 660
Groningen
9700 AR
Netherlands
| Phone | +31 (0)50 361 0973 |
|---|---|
| info@accare.nl | |
| Website | http://www.accare.nl/ |
"ROR" |
https://ror.org/02h4pw461 |
Funders
Funder type
Industry
Eli Lilly Holdings Limited (UK)
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 | 01/10/2006 | 26/03/2021 | Yes | No |
Editorial Notes
26/03/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
