Adderall XR Compared With Concerta in Treating Young Cancer Patients With Memory, Attention, and Depression

Depression Clinical Trial

Official title:

Adderall-XR Versus Concerta For Cancer Treatment-Related Neurocognitive Sequelae And Depression In Pediatric Patients: A Randomized Phase II Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00069927
• Other study ID #: SCUSF 0201
• Secondary ID: HLMCC-0201U10CA0
• Status: Terminated
• Phase: Phase 2
• First received: October 3, 2003
• Last updated: January 31, 2014
• Start date: August 2003
• Est. completion date: September 2006

Study information

• Verified date: January 2014
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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 (Adderall-XR®) vs methylphenidate (Concerta®).

• 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: September 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

INCLUSION CRITERIA:

• Between the ages of 6-17 at the time of study participation.

• Have a diagnosis of any malignancy that required CNS treatment such as surgery and/or irradiation and/or intrathecal chemotherapy. (Patients treated with systemic chemotherapy alone are not eligible to participate)

• Off treatment and cancer free for a minimum of 6 months.

• Have a proficiency in English.

EXCLUSION CRITERIA:

• Patients with an estimated intelligence quotient (IQ) of less than 65 (based on the Wide Range Achievement Test (WRAT-3) Reading subtest) are not eligible to continue on study.

• At least one standard deviation below the level of performance predicted by their IQ on at least 2 of the 3 WISC-III subtests.

• Diagnosed with Attention Deficit Disorder (ADD) or Attention Deficit Hyperactivity Disorder (ADHD) prior to their cancer diagnosis.

• Currently taking antidepressants, antipsychotics, or other stimulants.

• Are blind.

• Have glaucoma.

• Family history of motor and phonic tics or Tourette's syndrome.

• Have seizures not controlled by antiepileptic drugs. (Note: Patients who are not experiencing seizure activity, having been on a stable dose of an antiepileptic drug for at least 12 weeks may participate)

• Taking a monoamine oxidase (MAO) inhibitor.

• Have a history of cardiovascular disease, uncontrolled hypertension or hyperthyroidism.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Neurotoxicity
• Neurotoxicity Syndromes
• Unspecified Childhood Solid Tumor, Protocol Specific

Intervention

Drug:
• Adderall-XR®
Adderall-XR® 10 mg/day for 3-12 weeks depending on subject's response
• Concerta®
Concerta® 18 mg/day for 3-12 weeks depending on subject's response

Locations

Country	Name	City	State
United States	MBCCOP-Medical College of Georgia Cancer Center	Augusta	Georgia
United States	University of Florida Shands Cancer Center	Gainesville	Florida
United States	Wilford Hall Medical Center	Lackland Air Force Base	Texas
United States	Sacred Heart Children's Hospital	Pensacola	Florida
United States	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan
United States	CHRISTUS Santa Rosa Children's Hospital	San Antonio	Texas
United States	MBCCOP - South Texas Pediatrics	San Antonio	Texas
United States	CCOP - Florida Pediatric	Tampa	Florida
United States	St. Joseph's Children's Hospital of Tampa	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate as measured by Wechsler Intelligence Scale for Children-III (WISC III) subtest: Coding, Symbol Search and Digit Span at baseline, and 3 weeks after the start of study treatment		12 weeks	No
Secondary	Durability of response as measured by WISC III subtest: Coding, Symbol Search and Digit Span at 12 weeks after the start of study treatment		12 weeks	No
Secondary	Depression as measured by Children's Depression Inventory Short Version (CDI-S) at baseline, weeks 3 and 12		12 weeks	No