The "VIP-ADHD trial": Does brain arousal have prognostic value for predicting response to psychostimulants in adult ADHD patients?
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The "VIP-ADHD trial": Does brain arousal have prognostic value for predicting response to psychostimulants in adult ADHD patients? / Strauß, Maria; Petroff, David; Huang, Jue; Ulke, Christine; Paucke, Madlen; Bogatsch, Holger; Böhme, Pierre; Hoffmann, Knut; Reif, Andreas; Kittel-Schneider, Sarah; Heuser, Isabella; Ahlers, Eike; Gallinat, Juergen; Schöttle, Daniel; Fallgatter, Andreas; Ethofer, Thomas; Unterecker, Stefan; Hegerl, Ulrich.
in: EUR NEUROPSYCHOPHARM, Jahrgang 43, 02.2021, S. 116-128.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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T1 - The "VIP-ADHD trial": Does brain arousal have prognostic value for predicting response to psychostimulants in adult ADHD patients?
AU - Strauß, Maria
AU - Petroff, David
AU - Huang, Jue
AU - Ulke, Christine
AU - Paucke, Madlen
AU - Bogatsch, Holger
AU - Böhme, Pierre
AU - Hoffmann, Knut
AU - Reif, Andreas
AU - Kittel-Schneider, Sarah
AU - Heuser, Isabella
AU - Ahlers, Eike
AU - Gallinat, Juergen
AU - Schöttle, Daniel
AU - Fallgatter, Andreas
AU - Ethofer, Thomas
AU - Unterecker, Stefan
AU - Hegerl, Ulrich
N1 - Copyright © 2020 Elsevier B.V. and ECNP. All rights reserved.
PY - 2021/2
Y1 - 2021/2
N2 - EEG studies have shown that adult ADHD patients have less stable brain arousal regulation than age and gender matched controls. Psychostimulants have brain arousal stabilising properties evident in EEG patterns. The aim of this study was to investigate whether the stability of brain arousal regulation has prognostic value in predicting response to methylphenidate therapy in adult ADHD patients. In an open-label, single-arm, multi-centre, confirmatory trial, 121 adult ADHD patients were recruited and 112 qualified for the full analysis set. All participants received an initial dose of 20 mg extended release methylphenidate at baseline. After a titration phase of up to 4 weeks, patients remained on a weight-based target dose of extended release methylphenidate for 4 weeks. Using the Vigilance Algorithm Leipzig (VIGALL 2.1), we assessed brain arousal regulation before the treatment with methylphenidate, based on a 15-min EEG at quiet rest recorded at baseline. Using automatic stage-classification of 1 s segments, we computed the mean EEG-vigilance (indexing arousal level) and an arousal stability score (indexing arousal regulation). The primary endpoint was the association between successful therapy, defined by a 30% reduction in CAARS, and stable/unstable brain arousal. 52 patients (46%) showed an unstable brain arousal regulation of which 23% had therapy success. In the stable group, 35% had therapy success, implying an absolute difference of 12 percentage points (95% CI -5 to 29, p = 0.17) in the direction opposite to the hypothesized one. There were no new findings regarding the tolerability and safety of extended release methylphenidate therapy.
AB - EEG studies have shown that adult ADHD patients have less stable brain arousal regulation than age and gender matched controls. Psychostimulants have brain arousal stabilising properties evident in EEG patterns. The aim of this study was to investigate whether the stability of brain arousal regulation has prognostic value in predicting response to methylphenidate therapy in adult ADHD patients. In an open-label, single-arm, multi-centre, confirmatory trial, 121 adult ADHD patients were recruited and 112 qualified for the full analysis set. All participants received an initial dose of 20 mg extended release methylphenidate at baseline. After a titration phase of up to 4 weeks, patients remained on a weight-based target dose of extended release methylphenidate for 4 weeks. Using the Vigilance Algorithm Leipzig (VIGALL 2.1), we assessed brain arousal regulation before the treatment with methylphenidate, based on a 15-min EEG at quiet rest recorded at baseline. Using automatic stage-classification of 1 s segments, we computed the mean EEG-vigilance (indexing arousal level) and an arousal stability score (indexing arousal regulation). The primary endpoint was the association between successful therapy, defined by a 30% reduction in CAARS, and stable/unstable brain arousal. 52 patients (46%) showed an unstable brain arousal regulation of which 23% had therapy success. In the stable group, 35% had therapy success, implying an absolute difference of 12 percentage points (95% CI -5 to 29, p = 0.17) in the direction opposite to the hypothesized one. There were no new findings regarding the tolerability and safety of extended release methylphenidate therapy.
U2 - 10.1016/j.euroneuro.2020.12.003
DO - 10.1016/j.euroneuro.2020.12.003
M3 - SCORING: Journal article
C2 - 33388218
VL - 43
SP - 116
EP - 128
JO - EUR NEUROPSYCHOPHARM
JF - EUR NEUROPSYCHOPHARM
SN - 0924-977X
ER -