No registrations found.
ID
Source
Brief title
Health condition
Atomoxetine treatment.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in the ADHD-Rating Scale-I (ADHDRS).
Secondary outcome
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 Behavior Questionnaire (CSBQ);
6. Nisonger Child Behavior Rating Form;
7. Children's Yale-Brown Obsessive;
8. Compulsive Scale;
9. Child Health and Illness Profile-CE;
10. Cognitive Battery: WISC-III Mazes, WISC-III Working Memory;
11. Vineland Maladaptive Subscale;
12. Safety measures: routine lab, physical examination, EKG, open-ended questioning for adverse events.
Background summary
The aim of this study was to examine the tolerability and effectiveness of atomoxetine on attention-deficit/hyperactivity (ADHD) symptoms and autistic features in children with pervasive developmental disorders.
Study objective
Atomoxetine will be effective in reducing symptoms of inattention and overactivity in children and adolescents with ASD.
Study design
N/A
Intervention
Treatment with open label atomoxetine for 10 weeks.
Hanzeplein 1
Pieter W. Troost
Hanzeplein 1
Groningen 9713 GZ
The Netherlands
+31 (0)50 3681100
p.troost@accare.nl
Hanzeplein 1
Pieter W. Troost
Hanzeplein 1
Groningen 9713 GZ
The Netherlands
+31 (0)50 3681100
p.troost@accare.nl
Inclusion criteria
1. Males and females between the ages of at least 6 years of age and not more than 17 years of age at visit 1;
2. ASD (DSM-IV TR diagnosis of autistic disorder or Asperger’s disorder or PDD not otherwise specified, established by clinical assessment and corroborated by Autism Diagnostic Interview scores;
3. Patients must score greater than 4 on the CGI-Severity 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 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. 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).
Exclusion criteria
1. Patients who weigh less than 20 kg at study entry;
2. Females with a positive Beta HCG pregnancy test;
3. Patients with a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions;
4. DSM-IV TR diagnosis of a PDD 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 seizure disorder identified by history, physical examination, or laboratory tests.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL407 |
| NTR-old | NTR447 |
| Other | : N/A |
| ISRCTN | ISRCTN25479460 |