Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic ADHD.

This study has been completed.

Sponsor:

Information provided by:

Shire Development LLC

ClinicalTrials.gov Identifier:

NCT00152022

First received: September 7, 2005

Last updated: November 2, 2007

Last verified: November 2007

History of Changes

Tracking Information
First Received Date ^ICMJE	September 7, 2005
Last Updated Date	November 2, 2007
Start Date ^ICMJE	April 2005
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: September 7, 2005)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00152022 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 7, 2005)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic ADHD.
Official Title ^ICMJE	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).
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Attention Deficit Disorder With Hyperactivity.
Intervention ^ICMJE	Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulphate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.
Study Arm (s)	Not Provided
Publications *	Surman CB, Roth T. Impact of stimulant pharmacotherapy on sleep quality: post hoc analyses of 2 large, double-blind, randomized, placebo-controlled trials. J Clin Psychiatry. 2011 Jul;72(7):903-8. Brown TE, Landgraf JM. Improvements in executive function correlate with enhanced performance and functioning and health-related quality of life: evidence from 2 large, double-blind, randomized, placebo-controlled trials in ADHD. Postgrad Med. 2010 Sep;122(5):42-51.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	412
Completion Date	April 2006
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 55 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00152022
Other Study ID Numbers ^ICMJE	SPD465-303
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Shire Development LLC
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Shire Development LLC
Verification Date	November 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top