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van CCT (UK)

van CCT (UK)

Atomoxetine in children with pervasive developmental disorders.

- candidate number1588
- NTR NumberNTR447
- Date ISRCTN created26-feb-2007
- date ISRCTN requested18-nov-2005
- Date Registered NTR12-sep-2005
- Secondary IDsN/A 
- Public TitleAtomoxetine in children with pervasive developmental disorders.
- Scientific TitleAtomoxetine for Attention-Deficit Hyperactivity Disorder Symptoms in Children with Pervasive Developmental Disorders: a Pilot Study.
- hypothesisAtomoxetine will be effective in reducing symptoms of inattention and overactivity in children and adolescents with ASD.
- Healt Condition(s) or Problem(s) studiedAttention Deficit Hyperactivity Disorder (ADHD), Pervasive developmental disorder
- Inclusion criteria1. 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 Aspergerís 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 patientís 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 criteria1. 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, Aspergerís Disorder (e.g., Rettís 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 25-feb-2004
- planned closingdate20-okt-2004
- Target number of participants12
- InterventionsTreatment with open label atomoxetine for 10 weeks.
- Primary outcomeChange in the ADHD-Rating Scale-I (ADHDRS).
- Secondary outcome1. Clinical Global Impression Scale of improvement with regard to ADHD symptoms (CGI-ADHD-I);
2. The short form of the Connersí Parent Rating Scale-Revised (CPRS-R);
3. The short form of the Connersí Teacher Rating Scale-Revised (CTRS-R);
4. The Aberrant Behavior Checklist (ABC);
5. The Childrenís 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.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- Sponsor/Initiator Accare, Division University Center for Child and Adolescent Psychiatry
- Funding
(Source(s) of Monetary or Material Support)
Eli Lilly Nederland B.V.
- PublicationsPieter W. Troost, M.D., Mark-Peter Steenhuis, M.S., Hanneke G. Tuynman-Qua, M.D., Luuk Kalverdijk, M.D., Lawrence Scahill, M.S.N., Ph.D., Jan K. Buitelaar, M.D., Ph.D., Ruud B. Minderaa, M.D. Ph. D., Pieter J. Hoekstra, M.D., Ph. D. Atomoxetine for Attention-Deficit Hyperactivity Disorder Symptoms in Children with Pervasive Developmental Disorders: a Pilot Study. Submitted.
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD12-sep-2005 - 16-jun-2008

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