Atomoxetine for Children With Acquired Attentional Disorders Following Completion of Chemotherapy for ALL

• Status: Terminated
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Monarch Medical Research
• Collaborator: Eli Lilly and Company
• Treatments: Atomoxetine Hydrochloride

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.

• 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.