Harvey, Philip D.
Bowie, Christopher R.
McDonald, Sean
Podhorna, Jana
Clinical trials referenced in this document:
Documents that mention this clinical trial
Evaluation of the Efficacy of BI 425809 Pharmacotherapy in Patients with Schizophrenia Receiving Computerized Cognitive Training: Methodology for a Double-blind, Randomized, Parallel-group Trial
https://doi.org/10.1007/s40261-020-00893-8
Funding for this research was provided by:
Boehringer Ingelheim International GmbH
Article History
First Online: 8 February 2020
Compliance with Ethical Standards
:
: The work presented here was funded by the trial sponsor, Boehringer Ingelheim International GmbH (study number: 1346-0038, Clinicaltrials.gov identifier: NCT03859973). The sponsor was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.
: PDH has received consulting fees or travel reimbursements from Alkermes, Boehringer Ingelheim, Intra Cellular Therapies, Otsuka America, Roche, Sanofi Pharma, Sunovion Pharma, Takeda Pharma, and Teva Pharma during the past year. He has a research grant from Takeda and from the Stanley Medical Research Foundation. SM is an employee of Boehringer Ingelheim (Canada) Ltd. JP is an employee of Boehringer Ingelheim International GmbH. CRB has received consulting fees from Boehringer Ingelheim, Pfizer, and Lundbeck. He has research funding from Takeda, Lundbeck, and Pfizer, and has received in-kind research user accounts from Scientific Brain Training Pro.
: The trial will be carried out in compliance with the protocol, the ethical principles laid down in the Declaration of Helsinki, in accordance with the ICH-GCP, relevant Boehringer Ingelheim Standard Operating Procedures, and other current relevant regulations and has been approved by the local ethics committees of all participating study sites.
: Prior to patient participation in the trial, written informed consent must be obtained from each patient (or the patient’s legally accepted representative) according to International Conference on Harmonization-Good Clinical Practice (ICH-GCP) and to the regulatory and legal requirements of the participating country.