The "VIP-ADHD trial": Does brain arousal have prognostic value for predicting response to psychostimulants in adult ADHD patients?

Autor: Strauß M; Department of Psychiatry and Psychotherapy, University Hospital of Leipzig, Semmelweisstrasse 10, 04103 Leipzig, Germany. Electronic address: maria.strauss@medizin.uni-leipzig.de., Petroff D; Clinical Trial Centre Leipzig, Faculty of Medicine, University of Leipzig, Germany., Huang J; Department of Psychiatry and Psychotherapy, University Hospital of Leipzig, Semmelweisstrasse 10, 04103 Leipzig, Germany., Ulke C; Department of Psychiatry and Psychotherapy, University Hospital of Leipzig, Semmelweisstrasse 10, 04103 Leipzig, Germany., Paucke M; Department of Psychiatry and Psychotherapy, University Hospital of Leipzig, Semmelweisstrasse 10, 04103 Leipzig, Germany., Bogatsch H; Clinical Trial Centre Leipzig, Faculty of Medicine, University of Leipzig, Germany., Böhme P; Department of Psychiatry and Psychotherapy, University Hospital of Bochum, Germany., Hoffmann K; Department of Psychiatry and Psychotherapy, University Hospital of Bochum, Germany., Reif A; Department of Psychiatry, Psychotherapy and Psychosomatic, University Hospital of Frankfurt., Kittel-Schneider S; Department of Psychiatry, Psychotherapy and Psychosomatic, University Hospital of Frankfurt; Department of Psychiatry, Psychotherapy and Psychosomatic Medicine, University Hospital of Würzburg, Germany., Heuser I; Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, Germany., Ahlers E; Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, Germany., Gallinat J; Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf (UKE), Germany., Schöttle D; Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf (UKE), Germany., Fallgatter A; Department of Psychiatry and Psychotherapy, LEAD Graduate School and Research Network, University Hospital of Tübingen, Tübingen, Germany., Ethofer T; Department of Psychiatry and Psychotherapy, LEAD Graduate School and Research Network, University Hospital of Tübingen, Tübingen, Germany; Department of Biomedical Magnetic Resonance, University Hospital of Tübingen, Germany., Unterecker S; Department of Psychiatry, Psychotherapy and Psychosomatic Medicine, University Hospital of Würzburg, Germany., Hegerl U; Department of Psychiatry, Psychotherapy and Psychosomatic, University Hospital of Frankfurt.
Jazyk: angličtina
Zdroj: European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology [Eur Neuropsychopharmacol] 2021 Feb; Vol. 43, pp. 116-128. Date of Electronic Publication: 2020 Dec 31.
DOI: 10.1016/j.euroneuro.2020.12.003
Abstrakt: 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.
Competing Interests: Declaration of Competing Interest MS has received speaker fees from Lilly, Medice Arzneimitte Pütter GmbH & Co. KG and Servier and was an advisory board member for Shire/Takeda. AR has received speaker's honoraria and/or served on advisory boards for Medice, Shire/Takeda, Janssen, neuraxpharm, Sevier and SAGE. SKS received author's, speaker's and consultant's honoraria from Medice MEDICE Arzneimittel Pütter GmbH & Co. KG and Shire/Takeda. EA was an advisory board member for Shire/Takeda. JG has received research funding from the German Federal Ministry of Education and Research, German Science Foundation, and speaker fees from Sanofi, Lundbeck, Janssen-Cilag, Lilly and Otsuka. UH has received funding from Medice Arzneimittel Pütter GmbH & Co. KG and was a consultant for Medice Arzneimittel Pütter GmbH & Co. KG and an advisory board member for Janssen-Cilag. The other authors do not report any possible conflicts of interest.
(Copyright © 2020 Elsevier B.V. and ECNP. All rights reserved.)
Databáze: MEDLINE
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