Mandal, Sucharita
Mukhopadhyay, Kaushik
Guin, Aparajita
Sorkhel, Rupal
Mitra, Pulama
Ojha, Bisweswar
Verma, Kamini
Mukherjee, Sukriti
Funding for this research was provided by:
Indian Council of Medical Research (1753/2023)
Indian Council of Medical Research (1753/2023)
Indian Council of Medical Research (1753/2023)
Indian Council of Medical Research (1753/2023)
Indian Council of Medical Research (1753/2023)
Indian Council of Medical Research (1753/2023)
Indian Council of Medical Research (1753/2023)
Indian Council of Medical Research (1753/2023)
Article History
Received: 4 June 2025
Accepted: 25 August 2025
First Online: 24 November 2025
Change Date: 6 December 2025
Change Type: Update
Change Details: In the original publication, there was a typo in the word participants. The article has been updated to rectify the error.
Declarations
:
: The clinical trial commenced only after obtaining prior written approval from the Institutional Ethics Committee (IEC) of AIIMS Kalyani and successful registration with the Clinical Trials Registry - India (CTRI). As this is an academic clinical trial involving a drug already approved for a different indication (vortioxetine for major depressive disorder), permission from the Central Licensing Authority (CLA) under the DCGI was not required. The study adheres strictly to the ethical principles outlined in the Declaration of Helsinki and complies with the Indian Council of Medical Research (ICMR) guidelines for biomedical research involving human participants. Written informed consent is obtained from all participants in their native language, ensuring they fully understand the study procedures, potential risks, benefits, and their right to withdraw at any stage without any consequences. No participant is subjected to financial burden; all costs associated with the study are borne by the institution. The confidentiality of all participant data is maintained. Identifiable information is de-identified prior to analysis, and data is stored securely with restricted access limited to authorized study investigators. Participants are also provided with the contact details of both the principal investigator and the ethics committee to report any concerns or adverse events.
: Not applicable, as the protocol does not include any individual person’s data in any form, including images, videos, or clinical details.
: The authors declare no competing interests.