Safety and Efficacy of SPD465 in Adults With ADHD

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ClinicalTrials.gov Identifier: NCT00202605

Recruitment Status : Completed

First Posted : September 20, 2005

Last Update Posted : November 6, 2007

Sponsor:

Information provided by:

Shire

Study Description

Brief Summary:

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 or disease	Intervention/treatment	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 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	72 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	A Phase II, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Crossover Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
Study Start Date :	September 2005
Actual Study Completion Date :	April 2006

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Attention-deficit/hyperactivity disorder

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Dextroamphetamine sulfate Dextroamphetamine Amphetamine sulfate Amphetamine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

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)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202605

Locations

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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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wigal T, Childress A, Frick G, Yan B, Wigal S, Madhoo M. Effects of SHP465 mixed amphetamine salts in adults with ADHD in a simulated adult workplace environment. Postgrad Med. 2018 Jan;130(1):111-121. doi: 10.1080/00325481.2018.1389227. Epub 2017 Oct 31.

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ClinicalTrials.gov Identifier:	NCT00202605 History of Changes
Other Study ID Numbers:	SPD465-203
First Posted:	September 20, 2005 Key Record Dates
Last Update Posted:	November 6, 2007
Last Verified:	November 2007

Additional relevant MeSH terms:

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Amphetamine Dextroamphetamine Hyperkinesis Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Neurodevelopmental Disorders Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Central Nervous System Stimulants	Physiological Effects of Drugs Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Dopamine Uptake Inhibitors

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