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Efficacy of Atomoxetine Therapy Versus Placebo for Cognitive Late Effects

This study has been withdrawn prior to enrollment.
Eli Lilly and Company
Information provided by:
Temple University Identifier:
First received: November 15, 2005
Last updated: October 28, 2008
Last verified: October 2008
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 Intervention Phase
Cancer Cognitive Late Effects Drug: Atomoxetine Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Temple University:

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

Estimated Enrollment: 60
Study Start Date: November 2005
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.


Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Exclusion Criteria:

  • No ongoing pharmacological management of ADHD
  • Not currently pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00255138

United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
Eli Lilly and Company
Principal Investigator: Ronald T Brown, Ph.D. Temple University
  More Information Identifier: NCT00255138     History of Changes
Other Study ID Numbers: 4463
Study First Received: November 15, 2005
Last Updated: October 28, 2008

Keywords provided by Temple University:
Cognitive Late Effects

Additional relevant MeSH terms:
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs processed this record on August 22, 2017