The Safety and Efficacy of SPD465 in Adults With Attention Deficit Hyperactivity Disorder (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

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-14

Study Completion Date

2004-11-20

Brief Summary

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This is a phase 2, randomized, multi-center, double-blind, 3-period and 3-treatment crossover study designed to evaluate the safety and duration of efficacy of SPD465 (50 or 75 mg) compared with placebo and an immediate release amphetamine salt formulation (25 mg) in adults with ADHD. The controlled environment used in this study is an analog classroom setting adapted for a 16-hour adult day.

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Detailed Description

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Conditions

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Attention-Deficit/Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SPD465 (50 or 75 mg)

Group Type EXPERIMENTAL

SPD465

Intervention Type DRUG

50 or 75 mg once daily for 7 days

Immediate Release Amphetamine salt (25 mg)

Group Type ACTIVE_COMPARATOR

Immediate Release Amphetamine Salt

Intervention Type DRUG

25 mg once daily for 7 days

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Once daily for 7 days

Interventions

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SPD465

50 or 75 mg once daily for 7 days

Intervention Type DRUG

Immediate Release Amphetamine Salt

25 mg once daily for 7 days

Intervention Type DRUG

Placebo

Once daily for 7 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult men and non-pregnant women between the ages of 18 and 55
* Confirmed diagnosis of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
* Baseline ADHD score of at least 24

Exclusion Criteria

* Weight less than 100 pounds or greater than 250 pounds
* Psychiatric diagnosis such as a severe comorbid Axis II or Axis I disorder
* Pregnancy or breastfeeding
* History of seizures
* Positive urine drug screen

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No