Document is current

Article History

Received: 14 May 2025

Accepted: 8 December 2025

First Online: 27 January 2026

Declarations

:

: Jeffrey L. Cummings has provided consultation to Acadia, Acumen, ALZpath, Annovis, Aprinoia, Artery, Axsome, Biogen, Biohaven, BioXcel, Bristol-Myers Squibb, Eisai, Fosun, GAP Foundation, Green Valley, Janssen, Karuna, Kinoxis, Lighthouse, Lilly, Lundbeck, LSP/eqt, Mangrove Therapeutics, Merck, MoCA Cognition, New Amsterdam, Novo Nordisk, onocC4, Optoceutics, Otsuka, Oxford Brain Diagnostics, Praxis, Prothena, ReMYND, Roche, Scottish Brain Sciences, Signant Health, Simcere, Sinaptica, T-Neuro, TrueBinding, and Vaxxinity pharmaceutical, assessment, and investment companies. He owns the copyright of the Neuropsychiatric Inventory. Sanjeda R. Chumki, Denise Chang, Zhen Zhang, and Malaak Brubaker are full-time employees of Otsuka Pharmaceutical Development & Commercialization Inc. Nanco Hefting and Pedro Such are full-time employees of H. Lundbeck A/S. David Wang is a full-time employee of Lundbeck LLC. George T. Grossberg has received consulting fees from Acadia, Abbott, Axsome, Biogen, Bristol-Myers Squibb, BioXcel, Eisai, Karuna, Lundbeck, MapLight Therapeutics, Otsuka, and Takeda. He is on Safety Monitoring Committees for Anavex, Quince, Merck, Newron, and Oligomerix.

: No ethics approval was required for this pooled analysis of data from published clinical trials. The original trials were approved by relevant institutional review boards and independent ethics committees and were performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments.

: This pooled analysis used data from published clinical trials. All participants and/or their legal representatives provided written or electronic informed consent prior to the start of the original trials.

: Not applicable.

: To submit inquiries related to Otsuka clinical research, or to request access to individual participant data (IPD) associated with any Otsuka clinical trial, please visit . For all approved IPD access requests, Otsuka will share anonymized IPD on a remotely accessible data sharing platform.

: Not applicable.

: All authors contributed to the study conception and design. Data analysis was performed by Denise Chang and Zhen Zhang. All authors critically reviewed the manuscript for intellectual content. All authors read and approved the final manuscript.