Attention Deficit Disorder With HyperactivityPhase 3NCT00150579
Efficacy and Safety of SPD465 in Adults With ADHD
A Phase 3 study testing Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate in people with Attention Deficit Disorder With Hyperactivity, run by Shire.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 27 Jan 2005to 14 Jun 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Primary diagnosis of ADHD
- Baseline ADHD-RS-IV score >= 24
- Non-pregnant females of childbearing potential must comply with contraceptive restrictions
Who cannot join
- 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
About this 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).
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.
- Being tested
- Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, and the Endpoint (average of weeks 5, 6, 7).
Secondary outcomes (7)
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.
Measured: Baseline, and the Endpoint (average of weeks 5, 6, 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.
Measured: Baseline, and the Endpoint (average of weeks 5, 6, 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.
Measured: Baseline, and the Endpoint (average of weeks 5, 6, 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.
Measured: Baseline, and the Endpoint (average of weeks 5, 6, 7).
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 1
Measured: Baseline and Week 1.
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 4
Measured: Baseline and Week 4.
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 7
Measured: Baseline and Week 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study start27 Jan 2005
- Primary completion14 Jun 2005
- Study completion14 Jun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150579
- Sponsor's protocol ID
- SPD465-301
- Status last verified
- Jun 2021
- First submitted
- 6 Sep 2005
- Last updated
- 30 Jun 2021
- Results posted
- No
Publications
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.
PubMed 31228031Brown 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.
PubMed 20861587Spencer 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.
PubMed 19026251Spencer 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.
PubMed 19012813
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT00150579
- Acronym / sponsor ID
- SPD465-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2005 (actual)
- Primary completion
- 14 Jun 2005 (actual)
- Study completion
- 14 Jun 2005 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Primary diagnosis of ADHD
- Baseline ADHD-RS-IV score >= 24
- Non-pregnant females of childbearing potential must comply with contraceptive restrictions
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate | Drug | – |
Primary outcome
Change from Baseline in the ADHD-rating scale 4th Edition (ADHD-RS-IV) total score to the Endpoint assessment.
Time frame: Baseline, and the Endpoint (average of weeks 5, 6, 7).
The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
7 secondary outcomes
Change from Baseline in the Clinical Global Impression of Improvement scale (CGI-I) to the Endpoint assessment.
Time frame: Baseline, and the Endpoint (average of weeks 5, 6, 7).
Change from Baseline in the Time-Sensitive ADHD Symptom Scale (TASS) score to the Endpoint assessment.
Time frame: Baseline, and the Endpoint (average of weeks 5, 6, 7).
Change from Baseline in the Brown Attention Deficit Disorder Scale (BADDS) to the Endpoint assessment
Time frame: Baseline, and the Endpoint (average of weeks 5, 6, 7).
Change in Baseline in the Adult ADHD Impact Module (AIM-A) score to the Endpoint assessment
Time frame: Baseline, and the Endpoint (average of weeks 5, 6, 7).
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 1
Time frame: Baseline and Week 1.
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 4
Time frame: Baseline and Week 4.
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 7
Time frame: Baseline and Week 7.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Derived from this study: PubMed 31228031Surman 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.
- Derived from this study: PubMed 20861587Brown 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.
- Derived from this study: PubMed 19026251Spencer 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.
- Derived from this study: PubMed 19012813Spencer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate in people with Attention Deficit Disorder With Hyperactivity, run by Shire.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the ADHD-rating scale 4th Edition (ADHD-RS-IV) total score to the Endpoint assessment. (time frame: Baseline, and the Endpoint (average of weeks 5, 6, 7).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00150579, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.