Efficacy of Atomoxetine Therapy Versus Placebo for Cognitive Late Effects
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|ClinicalTrials.gov Identifier: NCT00255138|
Recruitment Status : Withdrawn
First Posted : November 17, 2005
Last Update Posted : October 31, 2008
|Condition or disease||Intervention/treatment||Phase|
|Cancer Cognitive Late Effects||Drug: Atomoxetine||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Efficacy of Atomoxetine Therapy Versus Placebo For Ameliorating Cognitive Late Effects Among Survivors of Childhood Cancers|
|Study Start Date :||November 2005|
- Conner's Parent Rating Scale (CPRS)
- Conner's Teacher Rating Scale (CTRS)
- Continuous Performance Test (CPT)
- Side Effects Rating Scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00255138
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19140|
|Principal Investigator:||Ronald T Brown, Ph.D.||Temple University|