Back to resultsEfficacy and Safety of SPD465 in Adults With Moderately Symptomatic ADHD.
Primary Purpose
Attention Deficit Disorder With Hyperactivity
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulphate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00152022
Brief Title
Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic ADHD.
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).
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 25, 2005 (Actual)
Primary Completion Date
November 4, 2005 (Actual)
Study Completion Date
November 4, 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
412 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulphate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.
Primary Outcome Measure Information:
Title
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
Description
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.
Time Frame
Baseline (following ADHD medication washout of 7-28 days)
Title
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
Description
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.
Time Frame
Week 1
Title
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
Description
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.
Time Frame
Week 2
Title
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
Description
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.
Time Frame
Week 3
Title
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
Description
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.
Time Frame
Week 4
Title
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
Description
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.
Time Frame
Week 5
Title
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
Description
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Clinical Global Impression of Improvement scale (CG(-I) - assessed at visits 1 through 6/Early Termination (ET)
Time Frame
Weeks 1, 2, 3, 4, 5, & 6
Title
Brown ADD Scale (BADDS) - completed at Baseline and 6/ET visits
Time Frame
Baseline visit and weeks 1, 2, 3, 4, 5, & 6
Title
Adult ADHD Impact Module (AIM-A)-completed at Baseline and 6/ET visits.
Time Frame
Baseline visit and weeks 1, 2, 3, 4, 5, & 6
Title
Pittsburgh Sleep Quality Index (PSQI) - taken at every visit from Baseline to study completion.
Time Frame
Baseline visit and weeks 1, 2, 3, 4, 5, & 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
21824454
Citation
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. doi: 10.4088/JCP.11m06838.
Results Reference
derived
PubMed Identifier
20861587
Citation
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. doi: 10.3810/pgm.2010.09.2200.
Results Reference
derived
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Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic ADHD.
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