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

Sponsored by:	Shire Pharmaceutical Development
Information provided by:	Shire Pharmaceutical Development
ClinicalTrials.gov Identifier:	NCT00152022

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 the participants sleep and how they perceive their quality of life.

Condition	Intervention	Phase
Attention Deficit Disorder With Hyperactivity.	Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulphate, 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 (CG(-I) - assessed at visits 1 through 6/Early Termination (ET)
Brown ADD Scale (BADDS) - completed at Baseline and 6/ET visits
Adult ADHD Impact Module (AIM-A)-completed at Baseline and 6/ET visits.
Pittsburgh Sleep Quality Index (PSQI) - taken at every visit from Baseline to study completion.

Estimated Enrollment:	412
Study Start Date:	April 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
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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Study ID Numbers:	SPD465-303
Study First Received:	September 7, 2005
Last Updated:	November 2, 2007
ClinicalTrials.gov Identifier:	NCT00152022 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
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Hyperkinesis
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