Effectiveness of an Extended Release Stimulant Medication in Treating Preschool Children With Attention Deficit Hyperactivity Disorder (The APS Study) - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00712699

Purpose

This study will evaluate the safety and effectiveness of extended release mixed amphetamine salts in treating preschool children with attention deficit hyperactivity disorder.

Condition	Intervention
Attention Deficit Disorder With Hyperactivity	Drug: Extended release mixed amphetamine salts Drug: Placebo

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder Dietary Sodium Methamphetamine

Drug Information available for: Sodium chloride Amphetamine Amphetamine sulfate Methamphetamine

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Official Title:

Placebo vs. Extended Release Stimulant Crossover Trial in Preschoolers With ADHD

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Composite Parent and Teacher Conners Rating Scale Score [ Time Frame: Measured weekly for 6 weeks ] [ Designated as safety issue: No ]
Tolerance of extended release mixed amphetamine salts [ Time Frame: Measured weekly for 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Clinical Global Impression- Improvement Score [ Time Frame: Measured weekly for 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:

30

Study Start Date:

June 2008

Estimated Study Completion Date:

August 2009

Estimated Primary Completion Date:

August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will first receive treatment with extended release mixed amphetamine salts for 3 weeks and then placebo for 3 weeks.	Drug: Extended release mixed amphetamine salts Participants will take a daily 5-mg dose for the first week, a daily 10-mg dose for the second week, and a daily 15-mg maximum dose by the third week. Drug: Placebo Participants will take a daily 5-mg dose for the first week, a daily 10-mg dose for the second week, and a daily 15-mg maximum dose by the third week.
2: Experimental Participants will first receive treatment with placebo for 3 weeks and then extended release mixed amphetamine salts for 3 weeks.	Drug: Extended release mixed amphetamine salts Participants will take a daily 5-mg dose for the first week, a daily 10-mg dose for the second week, and a daily 15-mg maximum dose by the third week. Drug: Placebo Participants will take a daily 5-mg dose for the first week, a daily 10-mg dose for the second week, and a daily 15-mg maximum dose by the third week.

Detailed Description:

Attention deficit hyperactivity disorder (ADHD) is a common developmental disorder that affects between 4% and 12% of school-aged children. Children with ADHD often show symptoms of hyperactivity, inattention, inability to sit still, trouble listening, excessive talking, and aggression. ADHD is generally not diagnosed and treated in children less than 6 years old because some symptoms of ADHD are difficult to distinguish from normal behaviors of preschool-aged children. However, some preschool children who exhibit symptoms indicative of ADHD and who have been carefully diagnosed by a health professional may benefit from early treatment to lower risk for functional impairment later in childhood. Currently, environmental changes, parent effectiveness training, and behavior therapy are the commonly used treatments for preschoolers with ADHD symptoms, but not all preschoolers respond well to such behavioral interventions. These children may benefit from medication treatment; however, the safety and effectiveness of ADHD medications in treating preschool-aged children is not well known. Extended release mixed amphetamine salts (XR-MAS), a stimulant medication, is a commonly prescribed and approved medication for treating ADHD in children 6 years and older. Further study is needed to determine how XR-MAS affects preschool-aged children with ADHD symptoms. This study will compare the safety and effectiveness of XR-MAS versus placebo in treating preschool children with ADHD.

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.

Eligibility

Ages Eligible for Study:

36 Months to 66 Months

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Living at home for at least 6 months with parent or caregiver
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:

Previous nonresponse to mixed amphetamine salts (defined as 2 weeks of persistent symptoms in spite of doses greater than or equal to 15 mg per day)
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712699

Contacts

Contact: John H. Fanton, MD	413-794-7492	john.fanton@bhs.org
Contact: Bruce D. Waslick, MD	413-794-7035 ext 2	bruce.waslick@bhs.org

Locations

United States, Massachusetts
Baystate Medical Center	Recruiting
Springfield, Massachusetts, United States, 01199
Principal Investigator: John H. Fanton, MD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

John H. Fanton, MD

Baystate Medical Center

More Information

Responsible Party:

Baystate Medical Center ( John H. Fanton, MD )

Study ID Numbers:

F32 MH078388, DDTR BK-TKFND

First Received:

July 8, 2008

Last Updated:

July 15, 2008

ClinicalTrials.gov Identifier:

NCT00712699

Health Authority:

United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Preschool
Children
ADHD
Medication

Controlled Study
Placebo
Mixed Amphetamine Salts

Study placed in the following topic categories:

Signs and Symptoms
Methamphetamine
Dopamine
Attention Deficit Disorder with Hyperactivity
Adderall
Mental Disorders

Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Amphetamine
Dyskinesias

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Sympathomimetics
Nervous System Diseases

Physiological Effects of Drugs
Central Nervous System Stimulants
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 07, 2009