Efficacy, Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2006-10-31

Brief Summary

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This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.

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Detailed Description

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Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.

Conditions

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Attention Deficit Disorder With Hyperactivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Methylphenidate Transdermal System

The duration of MTS patch wear was 9 hours per day. A new patch was applied each morning upon awakening.

Group Type ACTIVE_COMPARATOR

Methylphenidate Transdermal System

Intervention Type DRUG

MTS 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes

Placebo

The duration of placebo patch wear was 9 hours per day. A new patch was applied each morning upon awakening.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo patch 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes applied daily

Concerta

CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily

Group Type ACTIVE_COMPARATOR

Concerta

Intervention Type DRUG

CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily

Interventions

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Methylphenidate Transdermal System

MTS 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes

Intervention Type DRUG

Placebo

Placebo patch 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes applied daily

Intervention Type DRUG

Concerta

CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily

Intervention Type DRUG

Other Intervention Names

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MTS Sham Treatment Methylphenidate HCL

Eligibility Criteria

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Inclusion Criteria

* Subjects have primary diagnosis of ADHD
* Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test
* Subject has an IQ score of \>\_ 80
* Subject is able to complete as least the Basic Test of the PERMP assessment

Exclusion Criteria

* Subject has a comorbid psychiatric diagnosis such as Axis II disorders or severe Axis I disorders
* Subject is taking Strattera(r)
* Subject has a recent history of suspected substance abuse or dependence disorder

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No