Early improvement with cariprazine as a predictor of antidepressant, anxiolytic, and antimanic response in bipolar I mania and depression: A pooled post hoc analysis of randomized cariprazine trials.

Autor: Tohen M; Department of Psychiatry and Behavioral Sciences, University of New Mexico School of Medicine, Albuquerque, NM, USA., Yu J; AbbVie, Florham Park, NJ, USA., Kramer K; AbbVie, Florham Park, NJ, USA., Nguyen HB; AbbVie, Florham Park, NJ, USA. Electronic address: binh.nguyen@abbvie.com.
Jazyk: angličtina
Zdroj: Journal of affective disorders [J Affect Disord] 2024 Oct 01; Vol. 362, pp. 194-200. Date of Electronic Publication: 2024 Jun 26.
DOI: 10.1016/j.jad.2024.06.100
Abstrakt: Background: Early symptomatic improvement may predict treatment response in bipolar I disorder. Cariprazine has demonstrated early treatment effects in bipolar I depression and mania studies; therefore, we assessed whether early improvement with cariprazine predicts eventual treatment response.
Methods: Post hoc analyses used pooled data from randomized, double-blind, placebo-controlled bipolar I depression (NCT02670538, NCT02670551) and mania (NCT00488618, NCT01058096, NCT01058668) trials. In depression studies (cariprazine 1.5 mg/d, 3 mg/d, or placebo), early improvement in Montgomery-Åsberg Depression Rating Scale (MADRS) and Hamilton Anxiety Rating Scale (HAM-A) total scores (≥25 % improvement at day 15) and subsequent depressive/anxiety symptom response status (≥50 % improvement at week 6) were assessed. In mania studies (cariprazine 3-12 mg/d or placebo), early improvement in Young Mania Rating Scale (YMRS) total scores (≥25 % improvement at day 7) and manic symptom response status (≥50 % improvement at week 3) were assessed.
Results: Patients with bipolar I depression and early MADRS improvement were approximately 4- to 6-times as likely to achieve MADRS or HAM-A response than those without early improvement; patients with early HAM-A improvement were approximately 3- to 4-times as likely to achieve MADRS or HAM-A response. A subset of patients without early improvement with cariprazine 1.5 mg/d (20 %-31 %) subsequently responded following up-titration. Patients with mania and early YMRS improvement were approximately 5 times more likely to have manic symptom response than those without early improvement.
Limitations: Post hoc analysis; relatively short study durations; flexible-dosing (mania studies).
Conclusions: Early symptom improvement with cariprazine may inform therapeutic decisions for patients with bipolar I disorder.
Competing Interests: Declaration of competing interest Dr. Tohen was an employee of Lilly (1997 to 2008) and has received honoraria from or consulted for Abbott, AbbVie, AstraZeneca, Alkermes, Atai, Biohaven Pharmaceuticals, Squibb, Rapport Neurosciences, Lilly, Johnson & Johnson, Otsuka, Merck, Sunovion, Intra-Cellular Therapies, NeuroRX, Roche, Elan, Lundbeck, Teva, Minerva, Neurocrine Biosciences, NoemaPharma, Pfizer; his spouse was a full time employee at Lilly (1998–2013). J. Yu and H.-B. Nguyen are employees of AbbVie and may hold stock. K. Kramer is a former employee of AbbVie and may hold AbbVie stock.
(Copyright © 2024 AbbVie Inc. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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