The Use of Brexpiprazole Combined With a Stimulant in Adults With Treatment-Resistant Attention-Deficit/Hyperactivity Disorder.

Autor:	Reimherr FW; From the Department of Psychiatry, School of Medicine, University of Utah, Psychiatric and Behavioral Solutions, Salt Lake City, UT., Gift TE; Department of Psychiatry, School of Medicine, University of Rochester, Rochester, NY., Steans TA; Psychiatric and Behavioral Solutions, Salt Lake City, UT., Reimherr ML; Department of Statistics, Penn State University, State College, PA., Rosenberg LI; Center for Emotional Fitness, Galloway, NJ., Wilson M; Psychiatric and Behavioral Solutions, Salt Lake City, UT., Marchant BK; Psychiatric and Behavioral Solutions, Salt Lake City, UT.
Jazyk:	angličtina
Zdroj:	Journal of clinical psychopharmacology [J Clin Psychopharmacol] 2022 Sep-Oct 01; Vol. 42 (5), pp. 445-453. Date of Electronic Publication: 2022 Aug 18.
DOI:	10.1097/JCP.0000000000001592
Abstrakt:	Background: This is the first controlled pharmacologic study in either adults or children with uncomplicated, treatment-resistant attention-deficit/hyperactivity disorder (ADHD). This study augmented stimulant therapy with the atypical antipsychotic brexpiprazole. The Food and Drug Administration preapproved primary outcome measure (Conners' Adult ADHD Rating Scale [CAARS]) showed no drug-placebo differences. Often studies showing no efficacy on the prestudy, defined primary outcome variable go unpublished. While this is decried, publishing studies with equivocal results remains rare. This reanalysis highlights trends in secondary measures having implications for treatment and research regarding treatment resistant ADHD. Methods: Initially, 559 stimulant-naive and 174 prior stimulant nonresponders received methylphenidate osmotic-release oral system, dexmethylphenidate hydrochloride, lisdexamfetamine, or mixed amphetamine salts. After 5 weeks, 168 stimulant-naive patients and 68 prior stimulant nonresponders who failed treatment were randomized to brexpiprazole or placebo in a 2:1 ratio while the remaining were on the stimulant. Outcome was measured with the CAARS, Montgomery-Asberg Depression Rating Scale, Beck Depression Inventory, Clinical Global Impression, and the Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS). The WRAADDS contains 2 factors: attention and emotional dysregulation. Results: Stimulant-naive patients showed no improvement with adjunctive brexpiprazole. Prior stimulant nonresponders displayed no brexpiprazole effect on the CAARS, Montgomery-Asberg Depression Rating Scale, or Beck Depression Inventory. In contrast, the WRAADDS detected a trend in treatment benefit, primarily through emotional dysregulation symptoms. Adverse effects on brexpiprazole and placebo were equivalent. Conclusions: Brexpiprazole might be effective in ADHD adults who are nonresponders to 2 or more stimulants. Future trials in treatment-resistant ADHD should use a 1:1 randomization and use a measure of ADHD symptoms that includes emotional dysregulation. (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)
Databáze:	MEDLINE
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