Atomoxetine for Children With Acquired Attentional Disorders Following Completion of Chemotherapy for Acute Lymphocytic Leukemia
Overview
- Phase
- Phase 4
- Intervention
- Atomoxetine
- Conditions
- Attention Deficit Hyperactivity Disorder
- Sponsor
- Monarch Medical Research
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- The primary outcome is the change in the ADHD-RS total score from baseline to completion of the study.
- Status
- Terminated
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
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.
Arms & Interventions
2
placebo
Intervention: Atomoxetine
1
atomoxetine
Intervention: Atomoxetine
Outcomes
Primary Outcomes
The primary outcome is the change in the ADHD-RS total score from baseline to completion of the study.
Time Frame: 5 weeks
Secondary Outcomes
- The secondary outcome is the difference in CGI categories by the treatment versus placebo group.(5 weeks)