A Randomized, Phase 3, Double-Blind, Crossover Comparison of Multilayer, Extended-Release Methylphenidate (PRC-063), and Lisdexamfetamine in the Driving Performance of Young Adults With ADHD
OBJECTIVE: To compare PRC-063 (multilayer-release methylphenidate) and lisdexamfetamine dimesylate (LDX) on the driving performance of young adults with attention deficit hyperactivity disorder (ADHD) in a randomized, double-blind, crossover study.
METHOD: Following up to 21 days of each treatment in each treatment course (PRC-063/LDX or LDX/PRC-063), subjects completed a 15-hour driving simulator laboratory assessment. The primary outcome measure was the Tactical Driving Quotient (TDQ) and the Clinical Global Impressions-Improvement (CGI-I) scale was a secondary outcome measure.
RESULTS: Forty-four subjects completed the study. PRC-063 and LDX had equivalent effects on driving performance through a 15-hour time period (least square mean difference -0.3 [standard error 1.08], 95% confidence interval [-2.4, 1.8], p = .793). Consistent improvement in CGI-I was observed. The incidence of treatment-emergent adverse events was similar for each treatment sequence.
CONCLUSIONS: PRC-063 and LDX had comparable effects on driving performance, from 1 through 15 hours, the last time point measured.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:28 |
|---|---|
| Enthalten in: |
Journal of attention disorders - 28(2024), 6 vom: 22. Apr., Seite 947-956 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Madaan, Vishal [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 01.04.2024 Date Revised 15.04.2024 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1177/10870547241226634 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM368940071 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM368940071 | ||
| 003 | DE-627 | ||
| 005 | 20240415233254.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240229s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1177/10870547241226634 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1376.xml |
| 035 | |a (DE-627)NLM368940071 | ||
| 035 | |a (NLM)38404033 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Madaan, Vishal |e verfasserin |4 aut | |
| 245 | 1 | 2 | |a A Randomized, Phase 3, Double-Blind, Crossover Comparison of Multilayer, Extended-Release Methylphenidate (PRC-063), and Lisdexamfetamine in the Driving Performance of Young Adults With ADHD |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 01.04.2024 | ||
| 500 | |a Date Revised 15.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a OBJECTIVE: To compare PRC-063 (multilayer-release methylphenidate) and lisdexamfetamine dimesylate (LDX) on the driving performance of young adults with attention deficit hyperactivity disorder (ADHD) in a randomized, double-blind, crossover study | ||
| 520 | |a METHOD: Following up to 21 days of each treatment in each treatment course (PRC-063/LDX or LDX/PRC-063), subjects completed a 15-hour driving simulator laboratory assessment. The primary outcome measure was the Tactical Driving Quotient (TDQ) and the Clinical Global Impressions-Improvement (CGI-I) scale was a secondary outcome measure | ||
| 520 | |a RESULTS: Forty-four subjects completed the study. PRC-063 and LDX had equivalent effects on driving performance through a 15-hour time period (least square mean difference -0.3 [standard error 1.08], 95% confidence interval [-2.4, 1.8], p = .793). Consistent improvement in CGI-I was observed. The incidence of treatment-emergent adverse events was similar for each treatment sequence | ||
| 520 | |a CONCLUSIONS: PRC-063 and LDX had comparable effects on driving performance, from 1 through 15 hours, the last time point measured | ||
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a ADHD | |
| 650 | 4 | |a PRC-063 | |
| 650 | 4 | |a lisdexamfetamine dimesylate | |
| 650 | 4 | |a methylphenidate | |
| 650 | 4 | |a simulated driving performance | |
| 650 | 7 | |a Central Nervous System Stimulants |2 NLM | |
| 650 | 7 | |a Lisdexamfetamine Dimesylate |2 NLM | |
| 650 | 7 | |a SJT761GEGS |2 NLM | |
| 650 | 7 | |a Methylphenidate |2 NLM | |
| 650 | 7 | |a 207ZZ9QZ49 |2 NLM | |
| 700 | 1 | |a Bhaskar, Sailaja |e verfasserin |4 aut | |
| 700 | 1 | |a Donnelly, Graeme A E |e verfasserin |4 aut | |
| 700 | 1 | |a Cox, Daniel J |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Journal of attention disorders |d 1997 |g 28(2024), 6 vom: 22. Apr., Seite 947-956 |w (DE-627)NLM095560084 |x 1557-1246 |7 nnns |
| 773 | 1 | 8 | |g volume:28 |g year:2024 |g number:6 |g day:22 |g month:04 |g pages:947-956 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1177/10870547241226634 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 28 |j 2024 |e 6 |b 22 |c 04 |h 947-956 | ||