Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, and the Endpoint (average of weeks 5, 6, 7). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31228031 | Derived | 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. | |
| 20861587 | Derived |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000661 | Amphetamine |
| C007792 | Fumigant 93 |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Endpoint is the average of the values obtained at Weeks 5, 6, and 7. |
| 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. | 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. | Baseline, and the Endpoint (average of weeks 5, 6, 7). |
| Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 1 | Baseline and Week 1. |
| Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 4 | Baseline and Week 4. |
| Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 7 | Baseline and Week 7. |
| 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. |
| 19026251 | Derived | 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. |
| 19012813 | Derived | 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. |
| Organic Chemicals |