Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic ADHD.
July 7, 2021 updated by: Shire
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).
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.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment
412
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
Time Frame: Baseline (following ADHD medication washout of 7-28 days)
|
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.
|
Baseline (following ADHD medication washout of 7-28 days)
|
|
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
Time Frame: Week 1
|
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.
|
Week 1
|
|
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
Time Frame: Week 2
|
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.
|
Week 2
|
|
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
Time Frame: Week 3
|
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.
|
Week 3
|
|
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
Time Frame: Week 4
|
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.
|
Week 4
|
|
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
Time Frame: Week 5
|
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.
|
Week 5
|
|
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
Time Frame: Week 6
|
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.
|
Week 6
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Weeks 1, 2, 3, 4, 5, & 6
|
|
Brown ADD Scale (BADDS) - completed at Baseline and 6/ET visits
Time Frame: Baseline visit and weeks 1, 2, 3, 4, 5, & 6
|
Baseline visit and weeks 1, 2, 3, 4, 5, & 6
|
|
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
|
Baseline visit and weeks 1, 2, 3, 4, 5, & 6
|
|
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
|
Baseline visit and weeks 1, 2, 3, 4, 5, & 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 25, 2005
Primary Completion (Actual)
November 4, 2005
Study Completion (Actual)
November 4, 2005
Study Registration Dates
First Submitted
September 7, 2005
First Submitted That Met QC Criteria
September 7, 2005
First Posted (Estimate)
September 9, 2005
Study Record Updates
Last Update Posted (Actual)
July 13, 2021
Last Update Submitted That Met QC Criteria
July 7, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Neurologic Manifestations
- Dyskinesias
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Attention Deficit Disorder with Hyperactivity
- Hyperkinesis
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Sympathomimetics
- Adrenergic Uptake Inhibitors
- Amphetamine
- Dextroamphetamine
- Adderall
Other Study ID Numbers
- SPD465-303
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.