Attention Deficit Hyperactivity Disorder
Conditions
Keywords
Attention Deficit Hyperactivity Disorder
Brief summary
This study is a double-blind, placebo-controlled, parallel group trial of atomoxetine (1.8 mg/kg) for the management of chemotherapy-related acquired attentional disorders in children who have survived Acute Lymphocytic Leukemia. Atomoxetine will produce a favorable impact on ADHD symptoms in children with chemo-related acquired attentional disorders.
Detailed description
The primary objective of this study is to assess the safety, tolerability and efficacy of atomoxetine as determined by the change in the ADHD-RS-IV Total score compared to placebo in the symptomatic treatment of patients diagnosed with Attention-Deficit/Hyperactivity Disorder (by DSM-IV ADHD-NOS criteria) occurring as a neuropsychological late-effect of chemotherapy used to treat Acute Lymphocytic Leukemia (ALL). The secondary objectives are: 1. to assess the effect of once daily (AM) dosing of atomoxetine (1.8mg/kg) compared to placebo on ADHD symptoms as measured by: * ADHD-RS Total score inclusive of subtypes for inattention, hyperactivity and combined subtypes. * Clinical Global Impression-ADHD 2. to evaluate the safety and tolerability of atomoxetine compared with placebo based on treatment-emergent adverse events (AEs), laboratory tests, vital signs, physical examinations, and ECGs.
Interventions
DRUGAtomoxetine
titration schedule: 0.5 to 1.5 mg/kg/day
Sponsors
Eli Lilly and Company
Monarch Medical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Ages 6-18 years * Must have successfully completed treatment for ALL and are currently 1-year disease free as judged by the investigators. * Must meet DSM-IV criteria for ADHD-NOS.( Attachment A) The attention deficit symptoms have been precipitated by chemotherapy-related neurological injury. Therefore, the DSM-IV category is ADHD-NOS. * Must have an Investigator-completed ADHD-RS total and/or subscale score of ≥1.5 standard deviations above age/gender norm. * Laboratory results, including chemistries, hematology, and urinalysis do not demonstrate clinically significant abnormalities. * ECG demonstrates no clinically significant abnormalities * Educational level and degree of understanding of the patient and their parents permit suitable communication between the investigators and study coordinators. * Subjects and parents are judged to be reliable to keep appointments. * Must be able to swallow tablets. * Must have demonstrated compliance during their chemotherapy program. * Must weigh \> 20 kg.
Exclusion criteria
* Have relapsed or are having re-occurring symptoms/signs of ALL. * Have had substantial exposure to radiation therapy (\>2000: cGy) since high dose radiation treatment is associated with neurocognitive deficits or be treatment resistant pharmacologically. * Past exposure to atomoxetine. * ADHD symptoms or treatment prior to the diagnosis of ALL * Documented bipolar disorder, psychosis, affective disorder. * Female subjects who are pregnant or breastfeeding. * Suicide risk. * Seizure disorders (except history of febrile seizures). * Histories of multiple drug allergies. * Histories of alcohol or substance abuse. * Prior or current medical conditions that, in the opinion of the investigators, could be exacerbated by atomoxetine. * Sympathomimetic overactivity such as catecholamine secreting tumor. * Use of MAOI medications. * Have taken psychostimulants one week prior to randomization. * Current or past history of hypertension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the change in the ADHD-RS total score from baseline to completion of the study. | 5 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome is the difference in CGI categories by the treatment versus placebo group. | 5 weeks |
Countries
United States
Outcome results
None listed