Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 12:19 AM
NCT ID:
NCT05537558
Brief Summary:
Major depressive disorder (MDD) is the most common psychiatric disease worldwide with a huge socio-economic impact. Pharmacotherapy represents the first-line treatment choice; however, only about one third of patients respond to the first trial and about 30% are classified as treatment-resistant depression (TRD). TRD is associated with specific clinical features and genetic/gene expression signatures. To date, single sets of markers have shown limited power in response prediction. The aim of this project is the development of a precision medicine algorithm that would help early detection of non-responder patients, who might be more prone to later develop TRD.
In this phase of the project a naturalistic cohort of 300 MDD patients will be recruited. The data collected will be used to assess, in real-world conditions, the capability of an innovative algorithm (integrating clinical, omics and gender data of other 300 patients con MDD) to predict the treatment outcomes. This project represents a proof-of-concept study. The obtained results will provide information about the feasibility and usefulness of the proposed approach, with the perspective of designing future clinical trials in which algorithms could be tested as a predictive tool to drive decision making by clinicians, enabling a better prevention and management of MDD resistance.
Study:
NCT05537558
Study Brief:
Protocol Section:
NCT05537558