Clinical trial · Interventional
Adderall XR Compared With Concerta in Treating Young Cancer Patients With Memory, Attention, and Depression
Adderall-XR Versus Concerta For Cancer Treatment-Related Neurocognitive Sequelae And Depression In Pediatric Patients: A Randomized Phase II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Only 12 subjects enrolled. DSMB recommended closing due to lack of feasibility
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Depression | — | UNRESOLVED | — |
| Neurotoxicity | — | UNRESOLVED | — |
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adderall-XR® | Drug | — | UNRESOLVED |
| Concerta® | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1- Adderall- XR®
- description
- Adderall-XR® 1 10 mg/day for 3-12 weeks depending on subject's response
- interventionNames
- Drug: Adderall-XR®
- Drug: Concerta®
- type
- EXPERIMENTAL
- label
- Arm II Concerta®
- description
- Concerta ® 18 mg/day for 3-12 weeks depending on subject's response
- interventionNames
- Drug: Adderall-XR®
- Drug: Concerta®
Primary outcomes (1)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 17 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available