Effectiveness of an Extended Release Stimulant Medication in Treating Preschool Children With ADHD

NCT00712699 | Completed

• 2 other identifiers: F32MH078388DDTR BK-TKFND
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Preschool; Children; ADHD; Medication; Controlled Study; Placebo; Mixed Amphetamine Salts

Outcome Measures

Primary Outcomes (2)

• Composite Parent and Teacher Conners Rating Scale Score

  Measured weekly for 6 weeks

• Tolerance of extended release mixed amphetamine salts

  Measured weekly for 6 weeks

Secondary Outcomes (1)

• Clinical Global Impression- Improvement Score

  Measured weekly for 6 weeks

Study Arms (2)

Sequence 1: XR-MAS then placebo

EXPERIMENTAL

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.

Drug: Sequence 1: XR-MAS then placebo; Drug: Sequence 2 Placebo then XR-MAS

Sequence 2 Placebo then XR-MAS

EXPERIMENTAL

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.

Drug: Sequence 1: XR-MAS then placebo; Drug: Sequence 2 Placebo then XR-MAS

Interventions

Sequence 1: XR-MAS then placebo DRUG

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.

Also known as: Adderall XR, IND# 58,037

Sequence 1: XR-MAS then placebo; Sequence 2 Placebo then XR-MAS

Sequence 2 Placebo then XR-MAS DRUG

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 1: XR-MAS then placebo; Sequence 2 Placebo then XR-MAS

Eligibility Criteria

• Age: 36 Months - 66 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baystate Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

SLI381

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• John H. Fanton, MD

  Baystate Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: July 8, 2008
• First Posted: July 10, 2008
• Study Start: June 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 23, 2013

Record last verified: 2013-08