Efficacy and Safety of SPD465 in Adults With ADHD - Full Text View

Sponsored by:	Shire Pharmaceutical Development
Information provided by:	Shire Pharmaceutical Development
ClinicalTrials.gov Identifier:	NCT00150579

Purpose

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 sleep and how the participants perceive their quality of life.

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

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

Resource links provided by NLM:

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

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:

The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) taken at the Baseline visit and all visits thereafter.

Secondary Outcome Measures:

Clinical Global Impression of Improvement scale (CGI-I) - assessed at visits A1 through A7/Early Termination (ET)
Time-Sensitive ADHD Symptom Scale (TASS) - completed at the Baseline visit and twice daily throughout the remainder of the subjects participation in this study
Brown ADD Scale (BADDS) - completed at the Baseline and A7/ET visits
Adult ADHD Impact Module (AIM-A) - completed at the Baseline and A7/ET visits
Pittsburgh Sleep Quality Index (PSQI) - completed at every visit from Baseline to study completion/ET

Estimated Enrollment:	240
Study Start Date:	January 2005
Study Completion Date:	December 2005

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
Baseline ADHD-RS-IV score >= 24
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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided by Shire Pharmaceutical Development

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Spencer TJ, Landgraf JM, Adler LA, Weisler RH, Anderson CS, Youcha SH. Attention-deficit/hyperactivity disorder-specific quality of life with triple-bead mixed amphetamine salts (SPD465) in adults: results of a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2008 Nov;69(11):1766-75. Epub 2008 Nov 4.

Spencer TJ, Adler LA, Weisler RH, Youcha SH. Triple-bead mixed amphetamine salts (SPD465), a novel, enhanced extended-release amphetamine formulation for the treatment of adults with ADHD: a randomized, double-blind, multicenter, placebo-controlled study. J Clin Psychiatry. 2008 Sep;69(9):1437-48. Epub 2008 Sep 9.

Study ID Numbers:	SPD465-301
Study First Received:	September 6, 2005
Last Updated:	November 2, 2007
ClinicalTrials.gov Identifier:	NCT00150579 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
Aspartic Acid
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 August 30, 2009