Effectiveness of an Extended Release Stimulant Medication in Treating Preschool Children With ADHD
NCT ID: NCT00712699
Last Updated: 2013-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2008-06-30
2010-08-31
Brief Summary
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Detailed Description
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Participation in this study will last 6 weeks. All participants will first undergo rigorous psychiatric assessments to confirm their diagnosis of ADHD. Eligible participants will then be assigned randomly to receive treatment with either XR-MAS then placebo or placebo then XR-MAS. Participants will take their assigned XR-MAS or placebo medications for 3 weeks and then cross over to the other medication for an additional 3 weeks of treatment. Rating scale scores will be collected weekly from parents and teachers to assess symptom response and measures of safety.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Sequence 1: XR-MAS then placebo
Depending on whether 1) child has had previous medication trial or 2) is on psychotropic medication at time of screening, children will either enter the washout period of 3 days before extended release mixed amphetamine salts (XR-MAS) or placebo (PBO) is initiated or proceed directly to the active treatment sequence they were randomized to. Participants randomized to Sequence 1 first receive treatment with XR-MAR for 3 weeks and then placebo for 3 weeks. Flexible, forced dosing will start at 5 mg/day for the first week, increase to 10 mg/day for the second week and continue to 15 mg/day on the third week. No washout period otherwise occurs (XR-MAS is not clinically suspected to have lingering effects beyond initial dosing/day of administration), including the crossover week to PBO.
Sequence 1: XR-MAS then placebo
XR-MAS given in non-identifying 5 mg capsules with instructions to start 1 capsule (5 mg/d) for one week, then increase to 2 capsules (10 mg/d) for week two, and 3 caps (15 mg/d) for week 3 following flexible, forced titration based on response and tolerance.
Sequence 2 Placebo then XR-MAS
PBO given in non-identifying 5 mg capsules with instructions to start 1 capsule (5 mg/d) for one week, then increase to 2 capsules (10 mg/d) for week two, and 3 caps (15 mg/d) for week 3 following flexible, forced titration based on response and tolerance.
Sequence 2 Placebo then XR-MAS
Depending on whether 1) child has had previous medication trial or 2) is on psychotropic medication at time of screening, children will either enter the washout period of 3 days before extended release mixed amphetamine salts (XR-MAS) or placebo (PBO) is initiated or proceed directly to the active treatment sequence they were randomized to. Participants randomized to Sequence 2 will first receive treatment with PBO for 3 weeks and then XR-MAS for 3 weeks. Flexible, forced dosing will start at 5 mg/day for the first week, increase to 10 mg/day for the second week and continue to 15 mg/day on the third week. No washout period (stimulants are not clinically suspected to have lingering effects beyond initial dosing/day of administration)otherwise occurs, including the crossover week to XR-MAS.
Sequence 1: XR-MAS then placebo
XR-MAS given in non-identifying 5 mg capsules with instructions to start 1 capsule (5 mg/d) for one week, then increase to 2 capsules (10 mg/d) for week two, and 3 caps (15 mg/d) for week 3 following flexible, forced titration based on response and tolerance.
Sequence 2 Placebo then XR-MAS
PBO given in non-identifying 5 mg capsules with instructions to start 1 capsule (5 mg/d) for one week, then increase to 2 capsules (10 mg/d) for week two, and 3 caps (15 mg/d) for week 3 following flexible, forced titration based on response and tolerance.
Interventions
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Sequence 1: XR-MAS then placebo
XR-MAS given in non-identifying 5 mg capsules with instructions to start 1 capsule (5 mg/d) for one week, then increase to 2 capsules (10 mg/d) for week two, and 3 caps (15 mg/d) for week 3 following flexible, forced titration based on response and tolerance.
Sequence 2 Placebo then XR-MAS
PBO given in non-identifying 5 mg capsules with instructions to start 1 capsule (5 mg/d) for one week, then increase to 2 capsules (10 mg/d) for week two, and 3 caps (15 mg/d) for week 3 following flexible, forced titration based on response and tolerance.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Enrolled in a structured school setting at least 2 half days a week with a minimum of 7 peers
* Full Scale Intelligence Quotient (FSIQ) of 70 or greater OR 72 or greater if bilingual
* Best estimate diagnosis based on clinical interview, Diagnostic Interview Schedule for Children, Child Behavior Checklist, and rating scales scores
* Symptoms present for at least 9 months
* Meets severity criteria for Clinical Global Impression-Severity with score of greater than or equal to 4 and Clinical Global Assessment Scale score of greater than or equal to 55
* Parent/caregiver can commit to 6 weekly sessions, including initial screening exams
* If on current psychotropic medication, will undergo a washout period of at least 3 days before study entry
* Not currently receiving psychotherapy or started psychotherapy within 30 days of study entry
Exclusion Criteria
* Diagnosis of language-based or cognitive delay of more than 2 standard deviations below same-aged peers or diagnosis of mental retardation
* Pervasive developmental disorder or autism
* Significant developmental disorder (e.g., blindness, deafness, cerebral palsy, epilepsy, psychosis)
* Taking another psychotropic medication that cannot be discontinued
* Serious psychiatric disorder (e.g., bipolar, suicidality, tic disorder)
* Actively taking medication for certain medical conditions (e.g., hypertension, structural cardiac condition, glaucoma, hyperthyroidism)
* Allergy to mixed amphetamine salts
* History of physical, sexual, or emotional abuse that is clinically significant
36 Months
66 Months
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Baystate Medical Center
OTHER
Responsible Party
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john fanton
Primary Investigator
Principal Investigators
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John H. Fanton, MD
Role: PRINCIPAL_INVESTIGATOR
Baystate Medical Center
Countries
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Other Identifiers
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