Efficacy of Atomoxetine Therapy Versus Placebo for Cognitive Late Effects
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Efficacy of Atomoxetine Therapy Versus Placebo For Ameliorating Cognitive Late Effects Among Survivors of Childhood Cancers |
- Conner's Parent Rating Scale (CPRS)
- Conner's Teacher Rating Scale (CTRS)
- Continuous Performance Test (CPT)
- Side Effects Rating Scale
| Estimated Enrollment: | 60 |
| Study Start Date: | November 2005 |
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.
Eligibility| Ages Eligible for Study: | 6 Years to 18 Years |
| Genders Eligible for Study: | Both |
| 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| United States, Pennsylvania | |
| Temple University | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Principal Investigator: | Ronald T Brown, Ph.D. | Temple University |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00255138 History of Changes |
| Other Study ID Numbers: | 4463 |
| Study First Received: | November 15, 2005 |
| Last Updated: | October 28, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Temple University:
|
Cancer Cognitive Late Effects Stimulants |
Atomoxetine Attention Children |
Additional relevant MeSH terms:
|
Atomoxetine Adrenergic Uptake Inhibitors Adrenergic Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013