Safety and Efficacy of SPD465 in Adults With ADHD

This study has been completed.

First Received: September 12, 2005 Last Updated: November 2, 2007 History of Changes

Sponsored by:	Shire Pharmaceutical Development
Information provided by:	Shire Pharmaceutical Development
ClinicalTrials.gov Identifier:	NCT00202605

Purpose

The purpose of the study is to evaluate how safe and how well SPD465 works compared to placebo in adults with ADHD. It is hypothesized that SPD465 will achieve an extended duration of clinical benefit.

Condition	Intervention	Phase
Attention Deficit Disorder With Hyperactivity	Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d,I-amphetamine aspartate monohydrate	Phase II

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Dextroamphetamine sulfate Dextroamphetamine Amphetamine sulfate Amphetamine aspartate Amphetamine Methamphetamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Crossover Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:

PERMP (Permanent Product Measure of Performance) at 7 time points

Secondary Outcome Measures:

Time Segment Rating System (ADHD-RS[TSRS])
Subject self report (ADHD-SRS) of ADHD
Treatment emergent adverse events
Modified Pittsburgh Sleep Quality Index (PSQI)

Estimated Enrollment:	72
Study Start Date:	September 2005
Study Completion Date:	April 2006

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Primary diagnosis of ADHD using DSM-IV-TR criteria (at least 6 of the 9 subtype criteria met)
Baseline ADHD-RS-IV score =>24
IQ score of => 80 (using Kaufman Brief Intelligence Test)

Exclusion Criteria:

BMI < 18.5 or > 30 kg/m2
Diagnosis of Post Traumatic Stress Disorder, psychosis, bipolar illness, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder
History of seizure disorder or a lifetime history of any seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or family history of Tourette's Disorder
History of uncontrolled hypertension or currently hypertensive
Subjects who have taken atomoxetine (STRATTERA) within 30 days prior to screening
Current (or history within the last 12 months) of drug dependence or substance abuse disorder according to DSM-IV-TR criteria (excluding nicotine)
Female subject is pregnant or lactating, less than 3 months post partum

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202605

Locations

United States, Arkansas
Clinical Study Center
Little Rock, Arkansas, United States
United States, California
UCI Child Development Center
Irvine, California, United States
United States, Nevada
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, United States
United States, Texas
Bayou City Research, Ltd.
Houston, Texas, United States

Sponsors and Collaborators

Shire Pharmaceutical Development

More Information

No publications provided

Study ID Numbers:	SPD465-203
Study First Received:	September 12, 2005
Last Updated:	November 2, 2007
ClinicalTrials.gov Identifier:	NCT00202605 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Attention Deficit and Disruptive Behavior Disorders
Central Nervous System Stimulants
Dyskinesias
N-Methylaspartate
Signs and Symptoms
Methamphetamine
Dopamine

Attention Deficit Disorder with Hyperactivity
Mental Disorders
Dextroamphetamine
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations
Dopamine Agents
Amphetamine
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Signs and Symptoms
Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Disease

Sympathomimetics
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Central Nervous System Stimulants
Dyskinesias
Pharmacologic Actions
Methamphetamine
Autonomic Agents
Dextroamphetamine
Neurologic Manifestations
Amphetamine
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009