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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

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
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
Objective Sleep problems are common in adults with attention-deficit/hyperactivity disorder (ADHD). The presence of sleep problems at the time of presentation for ADHD treatment could impact the level of improvement in ADHD symptoms or executive function occurring with ADHD pharmacotherapy. Therefore, we examined the influence of baseline sleep quality on the effects of SHP465 mixed amphetamine salts (MAS) extended-release. Methods Adults (18–55 years) with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision-defined ADHD and baseline ADHD Rating Scale IV (ADHD-RS-IV) total scores ≥ 24 were randomized to once-daily SHP465 MAS (12.5–75 mg) or placebo in a 7-week, double-blind, dose-optimization study. Post-hoc analyses evaluated SHP465 MAS treatment effects on ADHD symptoms, using the ADHD-RS-IV, and executive function, using the Brown Attention-Deficit Disorder Scale (BADDS), based on baseline sleep quality as defined by Pittsburgh Sleep Quality Index (PSQI) scores [sleep quality impaired (PSQI total score > 5; PSQI component scores 2 or 3) versus not impaired (PSQI total score ≤ 5; PSQI component scores 0 or 1)]. Analyses were conducted in the intent-to-treat population. Results Of 280 enrolled participants, 272 were randomized (placebo, n = 135; SHP465 MAS, n = 137). The intent-to-treat population consisted of 268 participants (placebo, n = 132; SHP465 MAS, n = 136), and 170 participants (placebo, n = 76; SHP465 MAS, n = 94) completed the study. Treatment differences nominally favored SHP465 MAS over placebo in both sleep impairment groups regarding ADHD-RS-IV total score changes (all nominal p < 0.05), except for those with impairment defined by sleep efficiency (p = 0.2696), and regarding BADDS total score changes (all nominal p < 0.05), except for those with impairment defined by sleep duration (p = 0.1332) and sleep efficiency (p = 0.8226). There were no statistically significant differences in SHP465 MAS treatment effects between sleep impairment groups. Conclusions Improvements in ADHD symptoms and executive function occurred with dose-optimized SHP465 MAS, regardless of baseline impairment in some aspects of sleep in adults with ADHD, with no significant differences observed as a function of sleep impairment. Clinical Trials Registration ClinicalTrials.gov identifier—NCT00150579.
1172-7047
695-706
Surman, Craig
8725862f-4eef-46c5-b00a-5ec65b2247ef
Robertson, Brigitte
1d80620e-9809-4c1c-86c9-0ba7bb1e5cd2
Chen, Jie
7181526d-ec25-480e-a35e-37bf4616e131
Cortese, Samuele
53d4bf2c-4e0e-4c77-9385-218350560fdb
Surman, Craig
8725862f-4eef-46c5-b00a-5ec65b2247ef
Robertson, Brigitte
1d80620e-9809-4c1c-86c9-0ba7bb1e5cd2
Chen, Jie
7181526d-ec25-480e-a35e-37bf4616e131
Cortese, Samuele
53d4bf2c-4e0e-4c77-9385-218350560fdb

Surman, Craig, Robertson, Brigitte, Chen, Jie and Cortese, Samuele (2019) 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, 33 (7), 695-706. (doi:10.1007/s40263-019-00645-z).

Record type: Article

Abstract

Objective Sleep problems are common in adults with attention-deficit/hyperactivity disorder (ADHD). The presence of sleep problems at the time of presentation for ADHD treatment could impact the level of improvement in ADHD symptoms or executive function occurring with ADHD pharmacotherapy. Therefore, we examined the influence of baseline sleep quality on the effects of SHP465 mixed amphetamine salts (MAS) extended-release. Methods Adults (18–55 years) with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision-defined ADHD and baseline ADHD Rating Scale IV (ADHD-RS-IV) total scores ≥ 24 were randomized to once-daily SHP465 MAS (12.5–75 mg) or placebo in a 7-week, double-blind, dose-optimization study. Post-hoc analyses evaluated SHP465 MAS treatment effects on ADHD symptoms, using the ADHD-RS-IV, and executive function, using the Brown Attention-Deficit Disorder Scale (BADDS), based on baseline sleep quality as defined by Pittsburgh Sleep Quality Index (PSQI) scores [sleep quality impaired (PSQI total score > 5; PSQI component scores 2 or 3) versus not impaired (PSQI total score ≤ 5; PSQI component scores 0 or 1)]. Analyses were conducted in the intent-to-treat population. Results Of 280 enrolled participants, 272 were randomized (placebo, n = 135; SHP465 MAS, n = 137). The intent-to-treat population consisted of 268 participants (placebo, n = 132; SHP465 MAS, n = 136), and 170 participants (placebo, n = 76; SHP465 MAS, n = 94) completed the study. Treatment differences nominally favored SHP465 MAS over placebo in both sleep impairment groups regarding ADHD-RS-IV total score changes (all nominal p < 0.05), except for those with impairment defined by sleep efficiency (p = 0.2696), and regarding BADDS total score changes (all nominal p < 0.05), except for those with impairment defined by sleep duration (p = 0.1332) and sleep efficiency (p = 0.8226). There were no statistically significant differences in SHP465 MAS treatment effects between sleep impairment groups. Conclusions Improvements in ADHD symptoms and executive function occurred with dose-optimized SHP465 MAS, regardless of baseline impairment in some aspects of sleep in adults with ADHD, with no significant differences observed as a function of sleep impairment. Clinical Trials Registration ClinicalTrials.gov identifier—NCT00150579.

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Accepted/In Press date: 28 May 2019
e-pub ahead of print date: 21 June 2019
Published date: July 2019

Identifiers

Local EPrints ID: 431397
URI: http://eprints.soton.ac.uk/id/eprint/431397
ISSN: 1172-7047
PURE UUID: c5eae2e0-22b6-4748-9d29-090abd79b502
ORCID for Samuele Cortese: ORCID iD orcid.org/0000-0001-5877-8075

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Date deposited: 31 May 2019 16:30
Last modified: 16 Mar 2024 07:53

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Contributors

Author: Craig Surman
Author: Brigitte Robertson
Author: Jie Chen
Author: Samuele Cortese ORCID iD

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