DepressionPhase 2NCT00069927
Adderall XR Compared With Concerta in Treating Young Cancer Patients With Memory, Attention, and Depression
A Phase 2 study testing Adderall-XR® and Concerta® in people with Depression and Neurotoxicity, run by University of South Florida at 9 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Depression, Neurotoxicity, Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- Adderall-XR® and Concerta®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 9 sitesUnited States
- Study dates
- Aug 2003to Sep 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
MBCCOP-Medical College of Georgia Cancer Center
Augusta, Georgia, 30912-4000
University of Florida Shands Cancer Center
Gainesville, Florida, 32610-0296
Wilford Hall Medical Center
Lackland Air Force Base, Texas, 78236-5300
Sacred Heart Children's Hospital
Pensacola, Florida, 32504
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, 48073
CHRISTUS Santa Rosa Children's Hospital
San Antonio, Texas, 78207
MBCCOP - South Texas Pediatrics
San Antonio, Texas, 78229-3900
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, 33677-4227
CCOP - Florida Pediatric
Tampa, Florida, 33682-7757
About this study
Official title: Adderall-XR Versus Concerta For Cancer Treatment-Related Neurocognitive Sequelae And Depression In Pediatric Patients: A Randomized Phase II Study
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.
Read the detailed 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.
- Being tested
- Adderall-XR®, Concerta®
- Keywords
- unspecified childhood solid tumor, protocol specific, depression, neurotoxicity
- Medical subject headings
- Depression, Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adderall-XR®Drug
Also called dextroamphetamine-amphetamine
Adderall-XR® 10 mg/day for 3-12 weeks depending on subject's response
Concerta®Drug
Also called methylphenidate hydrochloride
Concerta® 18 mg/day for 3-12 weeks depending on subject's response
| Study group | Role | What they receive |
|---|---|---|
| Arm 1- Adderall- XR® | Experimental | Adderall-XR® 1 10 mg/day for 3-12 weeks depending on subject's response Receives: Drug: Adderall-XR®; Drug: Concerta® |
| Arm II Concerta® | Experimental | Concerta ® 18 mg/day for 3-12 weeks depending on subject's response Receives: Drug: Adderall-XR®; Drug: Concerta® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (2)
Durability of response as measured by WISC III subtest: Coding, Symbol Search and Digit Span at 12 weeks after the start of study treatment
Measured: 12 weeks
Depression as measured by Children's Depression Inventory Short Version (CDI-S) at baseline, weeks 3 and 12
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2003 (estimated)
- Study startAug 2003
- Primary completionJun 2006
- Study completionSep 2006
Why it stopped: Only 12 subjects enrolled. DSMB recommended closing due to lack of feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Margaret Booth-Jones, PhD, Study chair, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00069927
- Sponsor's protocol ID
- SCUSF 0201
- Other IDs
- HLMCC-0201, U10CA081920, SCUSF-0201
- Status last verified
- Jan 2014
- First submitted
- 3 Oct 2003
- Last updated
- 3 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adderall-XR Versus Concerta For Cancer Treatment-Related Neurocognitive Sequelae And Depression In Pediatric Patients: A Randomized Phase II Study
- ClinicalTrials.gov ID
- NCT00069927
- Acronym / sponsor ID
- SCUSF 0201
- Keywords
- unspecified childhood solid tumor, protocol specific, depression, neurotoxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Only 12 subjects enrolled. DSMB recommended closing due to lack of feasibility
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2003
- Primary completion
- Jun 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 7 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1- Adderall- XR® | Experimental | Drug: Adderall-XR®, Drug: Concerta®Adderall-XR® 1 10 mg/day for 3-12 weeks depending on subject's response |
| Arm II Concerta® | Experimental | Drug: Adderall-XR®, Drug: Concerta®Concerta ® 18 mg/day for 3-12 weeks depending on subject's response |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adderall-XR®Also: dextroamphetamine-amphetamineAdderall-XR® 10 mg/day for 3-12 weeks depending on subject's response | Drug | Arm 1- Adderall- XR®, Arm II Concerta® |
| Concerta®Also: methylphenidate hydrochlorideConcerta® 18 mg/day for 3-12 weeks depending on subject's response | Drug | Arm 1- Adderall- XR®, Arm II Concerta® |
Primary outcome
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
Time frame: 12 weeks
2 secondary outcomes
Durability of response as measured by WISC III subtest: Coding, Symbol Search and Digit Span at 12 weeks after the start of study treatment
Time frame: 12 weeks
Depression as measured by Children's Depression Inventory Short Version (CDI-S) at baseline, weeks 3 and 12
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Only 12 subjects enrolled. DSMB recommended closing due to lack of feasibility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Booth-Jones, PhD study chair
University of South Florida
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adderall-XR® and Concerta® in people with Depression and Neurotoxicity, run by University of South Florida at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Only 12 subjects enrolled. DSMB recommended closing due to lack of feasibility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2014.