Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic 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

PHASE3

Total Enrollment

412 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-25

Study Completion Date

2005-11-04

Brief Summary

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The purpose of this study is to assess the safety and effectiveness of SPD465 compared to placebo (a capsule with no medication in it) in the treatment of ADHD. The study will also look at how SPD465 affects the participants sleep and how they perceive their quality of life.

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Detailed Description

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Conditions

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Attention Deficit Disorder With Hyperactivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulphate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Primary diagnosis of ADHD
* Baseline ADHD-RS-IV score \>= 32
* Non-pregnant females of childbearing potential must comply with contraceptive restrictions.

Exclusion Criteria

* Significantly underweight or morbidly obese
* Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Axis I disorders
* History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder
* Females who are pregnant or lactating

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No