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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulphate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate. | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) | 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) | 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) | 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) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression of Improvement scale (CG(-I) - assessed at visits 1 through 6/Early Termination (ET) | Weeks 1, 2, 3, 4, 5, & 6 | |
| Brown ADD Scale (BADDS) - completed at Baseline and 6/ET visits | Baseline visit and weeks 1, 2, 3, 4, 5, & 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21824454 | Derived | 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. | |
| 20861587 | Derived | 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. |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000661 | Amphetamine |
| C007792 | Fumigant 93 |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 |
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| Week 4 |
| 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. | Week 5 |
| 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. | Week 6 |
| Adult ADHD Impact Module (AIM-A)-completed at Baseline and 6/ET visits. | Baseline visit and weeks 1, 2, 3, 4, 5, & 6 |
| Pittsburgh Sleep Quality Index (PSQI) - taken at every visit from Baseline to study completion. | Baseline visit and weeks 1, 2, 3, 4, 5, & 6 |
| Organic Chemicals |