Back to resultsEfficacy and Safety of SPD465 in Adults With 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 sulfate, 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 >= 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
Sites / Locations
Outcomes
Primary Outcome Measures
Change from Baseline in the ADHD-rating scale 4th Edition (ADHD-RS-IV) total score to the Endpoint assessment.
The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
Secondary Outcome Measures
Change from Baseline in the Clinical Global Impression of Improvement scale (CGI-I) to the Endpoint assessment.
The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
Change from Baseline in the Time-Sensitive ADHD Symptom Scale (TASS) score to the Endpoint assessment.
The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
Change from Baseline in the Brown Attention Deficit Disorder Scale (BADDS) to the Endpoint assessment
The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
Change in Baseline in the Adult ADHD Impact Module (AIM-A) score to the Endpoint assessment
The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 1
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 4
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 7
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00150579
Brief Title
Efficacy and Safety of SPD465 in Adults With 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
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 27, 2005 (Actual)
Primary Completion Date
June 14, 2005 (Actual)
Study Completion Date
June 14, 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 sleep and how the participants 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
240 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate
Primary Outcome Measure Information:
Title
Change from Baseline in the ADHD-rating scale 4th Edition (ADHD-RS-IV) total score to the Endpoint assessment.
Description
The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
Time Frame
Baseline, and the Endpoint (average of weeks 5, 6, 7).
Secondary Outcome Measure Information:
Title
Change from Baseline in the Clinical Global Impression of Improvement scale (CGI-I) to the Endpoint assessment.
Description
The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
Time Frame
Baseline, and the Endpoint (average of weeks 5, 6, 7).
Title
Change from Baseline in the Time-Sensitive ADHD Symptom Scale (TASS) score to the Endpoint assessment.
Description
The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
Time Frame
Baseline, and the Endpoint (average of weeks 5, 6, 7).
Title
Change from Baseline in the Brown Attention Deficit Disorder Scale (BADDS) to the Endpoint assessment
Description
The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
Time Frame
Baseline, and the Endpoint (average of weeks 5, 6, 7).
Title
Change in Baseline in the Adult ADHD Impact Module (AIM-A) score to the Endpoint assessment
Description
The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
Time Frame
Baseline, and the Endpoint (average of weeks 5, 6, 7).
Title
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 1
Time Frame
Baseline and Week 1.
Title
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 4
Time Frame
Baseline and Week 4.
Title
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 7
Time Frame
Baseline and Week 7.
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 >= 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
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
31228031
Citation
Surman CBH, Robertson B, Chen J, Cortese S. Post-Hoc Analyses of the Effects of Baseline Sleep Quality on SHP465 Mixed Amphetamine Salts Extended-Release Treatment Response in Adults with Attention-Deficit/Hyperactivity Disorder. CNS Drugs. 2019 Jul;33(7):695-706. doi: 10.1007/s40263-019-00645-z.
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
PubMed Identifier
19026251
Citation
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. doi: 10.4088/jcp.v69n1112. Epub 2008 Nov 4.
Results Reference
derived
PubMed Identifier
19012813
Citation
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. doi: 10.4088/jcp.v69n0911. Epub 2008 Sep 9.
Results Reference
derived
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Efficacy and Safety of SPD465 in Adults With ADHD
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