A prospective cohort study of depression (PROUD) in China: rationale and design.

ABSTRACT

Background: Major depressive disorder (MDD) imposes a heavy global disease burden. However, current etiology, diagnosis and treatment remain unsatisfactory and no previous study has resolved this problem. Building on the strengths and limitations of previous cohort studies of MDD, the prospective cohort study of depression (PROUD) is a 3-year large-scale cohort study designed to collect multidimensional data with a flexible follow-up schedule and strategy. The goal is to establish a nationally representative, high-quality, standardized depression cohort to support precise diagnosis and treatment of MDD and address the gap in current research. Methods: PROUD is a patient-based, nationally representative multicenter prospective cohort study with baseline and 3-year follow-up assessments. It will be carried out from January 2022 to December 2026 in 52 qualified tertiary hospitals in China. A total of 14,000 patients diagnosed with MDD, according to the DSM-5 criteria, and aged ≥ 16 years, will be recruited to PROUD. Participants aged 18-65 years who have not received any treatment during a depressive episode will be included in the precision medicine cohort (PMC) of PROUD (n=4,000). Patients who meet the general eligibility criteria but not the PMC criteria will be included in the naturalistic observation cohort (NOC) of PROUD (n=10,000). A multiple follow-up strategy, including scheduled, remote, telephone, external visits and patient self-reports, will be implemented to collect comprehensive sociodemographic, clinical information, biospecimens, neuroimaging, cognitive function and electrophysiology data and digital phenotypes according to strict standard operating procedures implemented across centers. Trial registration ChiCTR2200059053, registered on 23 April 2022, http//www.chictr.org.cn/showproj.aspx?proj=165790. Conclusions: PROUD is a prospective cohort study of MDD patients in China. It will provide a comprehensive database facilitating further analyses and aiding the development of homeostatic and precision medicine in China.