Efficacy of Atomoxetine Therapy Versus Placebo for Cognitive Late Effects

Sponsor

Temple University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00255138

Collaborator

Eli Lilly and Company (Industry)

Enrollment

Location

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the effectiveness and safety of atomoxetine in enhancing attention and concentration among childhood survivors of cancer.

Condition or Disease	Intervention/Treatment	Phase
Cancer Cognitive Late Effects	Drug: Atomoxetine	Phase 3

Detailed Description

In previous years, it had often been assumed that cognitive and behavioral declines in children who survived cancer therapy were largely a function of the prophylactic therapies (e.g., radiation, chemotherapy) that these children had received. Regardless of the etiologies of these specific late effects, the data regarding the long-term outcome of these children are strikingly consistent. Generally, the studies to date suggest significant impairments in attention and concentration that result in marked declines in academic performance and social and behavior difficulties.

Despite the clear evidence of problems with attention and concentration, as well as associated fucntional impairments (e.g., poor academic achievement and poor peer relationships), there have been few clinical trials designed to manage the cogntive late effects and neurological toxicities associated with radiation therapy and chemotherapy for children and adolescents who have survived cancer.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Efficacy of Atomoxetine Therapy Versus Placebo For Ameliorating Cognitive Late Effects Among Survivors of Childhood Cancers

Anticipated Study Start Date :

Nov 1, 2005

Outcome Measures

Primary Outcome Measures

Conner's Parent Rating Scale (CPRS) []

Secondary Outcome Measures

Conner's Teacher Rating Scale (CTRS) []
Continuous Performance Test (CPT) []
Side Effects Rating Scale []

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 6-18
Patient has received chemotherapy, radiation, or a combination of both.
Patient is at least 12 months post-competion of therapy but no more than five years post-completion of therapy.