Advertisement

Topics

Dextroamphetamine-Amphetamine Compared With Methylphenidate in Treating Children Who Have Problems With Memory, Attention, Thinking, and Depression Caused By Cancer Treatment

2014-08-27 03:54:53 | BioPortfolio

Summary

RATIONALE: Stimulant drugs such as dextroamphetamine-amphetamine and methylphenidate may help improve memory, attention, and thinking problems caused by central nervous system (CNS) treatment for cancer, and may help decrease depression.

PURPOSE: This randomized phase II trial is studying dextroamphetamine-amphetamine to see how well it works compared to methylphenidate in treating depression and problems with memory, attention, and thinking in children who have undergone CNS treatment for cancer. This trial will also study how often depression is seen and if these medications might help.

Description

OBJECTIVES:

- Compare the response rates in pediatric cancer patients with treatment-related neurocognitive sequelae treated with dextroamphetamine-amphetamine vs methylphenidate.

- Compare the durability of response at 12 weeks in patients who show a response at 3 weeks after treatment with these drugs.

- Determine whether patients who have no response to one of these study drugs can respond to the other study drug.

- Determine the prevalence of depression and possible response to neurostimulant therapy in this patient population.

OUTLINE: This is a randomized, multicenter study.

Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral dextroamphetamine-amphetamine once daily for 3 weeks. Patients who achieve response (based on neurocognitive testing) continue treatment for a total of 12 weeks. Patients with no response after 3 weeks cross over to arm II after a 48-hour washout period.

- Arm II: Patients receive oral methylphenidate once daily for 3 weeks. Responding patients continue treatment for a total of 12 weeks. Patients with no response after 3 weeks cross over to arm I after a 48-hour washout period.

Depression and neurocognitive function are assessed at baseline, 3 weeks, and end of study.

PROJECTED ACCRUAL: A total of 177 patients (approximately 88 per treatment arm) will be accrued for this study within 3 years.

Study Design

Allocation: Randomized, Control: Active Control, Primary Purpose: Supportive Care

Conditions

Depression

Intervention

dextroamphetamine-amphetamine, methylphenidate hydrochloride

Location

University of Florida Shands Cancer Center
Gainesville
Florida
United States
32610-0296

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:53-0400

Clinical Trials [1712 Associated Clinical Trials listed on BioPortfolio]

Dextroamphetamine as an Adjunct in Cocaine Treatment - 1

The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in cocaine treatment; an evaluation of the ""replacement"" strategy.

Dextroamphetamine-Cocaine Behavioral Intervention - 5

The purpose of this study is to examine dextroamphetamine-cocaine behavioral intervention in cocaine dependent patients.

Safety of SPD465 in Treating Adults With ADHD.

The purpose of this study is to assess the safety and effectiveness of SPD465 in the treatment of ADHD. The study will also look at how SPD465 affects sleep.

Safety and Efficacy of SPD465 in Adults With ADHD

The purpose of the study is to evaluate how safe and how well SPD465 works compared to placebo in adults with ADHD. It is hypothesized that SPD465 will achieve an extended duration of cli...

Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic ADHD.

The purpose of this study is to assess the safety and effectiveness of SPD465 compared to placebo (a capsule with no medication in it) in the treatment of ADHD. The study will also look a...

PubMed Articles [2818 Associated PubMed Articles listed on BioPortfolio]

False-Positive Dopamine Transporter Imaging Due to Therapeutic Dextroamphetamine/Amphetamine.

Dopamine transporter (DAT) single-photon emission computed tomography (SPECT) is an accurate adjunct to clinical evaluation for Parkinson's disease (PD) in cases where the diagnosis is difficult. Dopa...

Infant Exposure to Methylphenidate and Duloxetine During Lactation: A Case Report.

Duloxetine and methylphenidate are commonly prescribed for the management of depression and attention-deficit/hyperactivity disorder (ADHD), respectively. However, little information is available conc...

Involvement of NO/NMDA-R pathway in the behavioral despair induced by amphetamine withdrawal.

Abrupt discontinuation of chronic amphetamine consumption leads to withdrawal symptoms including depression, anhedonia, dysphoria, fatigue, and anxiety. These irritating symptoms may result in continu...

Mifepristone reduces hypothalamo-pituitary-adrenal axis activation and restores weight loss in rats subjected to dietary restriction and methylphenidate administration.

This study evaluates the efficacy of mifepristone on weight restoration in rats subjected to dietary restriction and methylphenidate administration. 25 female rats aged between 9 and 12 months were di...

Neurocognitive effects of methylphenidate in adults with attention-deficit/hyperactivity disorder: A meta-analysis.

PIEVSKY, M. A., and R. E. McGrath. Neurocognitive effects of methylphenidate in adults with attention-deficit/hyperactivity disorder: A meta-analysis…NEUROSCI BIOBEHAV REV 81(1) XXX-XXX, 2017.- This...

Medical and Biotech [MESH] Definitions

A powerful central nervous system stimulant and sympathomimetic. Amphetamine has multiple mechanisms of action including blocking uptake of adrenergics and dopamine, stimulation of release of monamines, and inhibiting monoamine oxidase. Amphetamine is also a drug of abuse and a psychotomimetic. The l- and the d,l-forms are included here. The l-form has less central nervous system activity but stronger cardiovascular effects. The d-form is DEXTROAMPHETAMINE.

The d-form of AMPHETAMINE. It is a central nervous system stimulant and a sympathomimetic. It has also been used in the treatment of narcolepsy and of attention deficit disorders and hyperactivity in children. Dextroamphetamine has multiple mechanisms of action including blocking uptake of adrenergics and dopamine, stimulating release of monamines, and inhibiting monoamine oxidase. It is also a drug of abuse and a psychotomimetic.

A central nervous system stimulant used most commonly in the treatment of attention-deficit disorders in children and for narcolepsy. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE.

A methylphenidate derivative, DOPAMINE UPTAKE INHIBITOR and CENTRAL NERVOUS SYSTEM STIMULANT that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.

A propylamine formed from the cyclization of the side chain of amphetamine. This monoamine oxidase inhibitor is effective in the treatment of major depression, dysthymic disorder, and atypical depression. It also is useful in panic and phobic disorders. (From AMA Drug Evaluations Annual, 1994, p311)

More From BioPortfolio on "Dextroamphetamine-Amphetamine Compared With Methylphenidate in Treating Children Who Have Problems With Memory, Attention, Thinking, and Depression Caused By Cancer Treatment"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Neurology - Central Nervous System (CNS)
Alzheimer's Disease Anesthesia Anxiety Disorders Autism Bipolar Disorders Dementia Epilepsy Multiple Sclerosis (MS) Neurology Pain Parkinson's Disease Sleep Disorders Neurology is the branch of me...

Head and neck cancers
Cancer can occur in any of the tissues or organs in the head and neck. There are over 30 different places that cancer can develop in the head and neck area. Mouth cancers (oral cancers)  - Mouth cancer can develop on the lip, the tongue, the floor...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...


Searches Linking to this Trial