Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder in Japan (PERFORM-J): Protocol for a Prospective Cohort Study.

BACKGROUND: Patients with major depressive disorder may exhibit cognitive dysfunction that can affect functional outcomes. However, the prevalence and burden of cognitive dysfunction in Japanese patients with MDD have not been thoroughly examined.

OBJECTIVE: To investigate the time course (over 6 months) of several functional outcomes during treatment with antidepressants in Japanese patients with major depressive disorder. The primary objective is to assess longitudinal changes in cognitive function and depressive symptoms, using both clinician-rated and patient-rated scales. The study incorporates assessments of cognitive function and other functional outcomes (functional capacity, disability, work productivity and impairments of activity, and quality of life), as well as depressive symptoms.

METHODS: PERFORM-J (Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder in Japan) is a 6-month, prospective, multi-center, epidemiological cohort study. Participants are Japanese outpatients aged 18-65 years with a recurrent or new diagnosis of a major depressive episode (according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision [DSM-IV-TR]), who are initiating a new antidepressant as monotherapy (either as first-line therapy or after switching from a previous antidepressant). Eligible patients are evaluated objectively during four visits (at baseline and at Months 1, 2, and 6) using physician-rated assessments of severity of depressive symptoms, cognitive function, and functional capacity. Subjective, patient-reported, outcomes are also assessed as indicators of depressive symptoms, disability, work productivity or impairments of activity, and perceived cognitive dysfunction.

RESULTS: The study began in September 2016. Patient enrollment was completed on June 30, 2017, with 523 patients having been enrolled from 48 study sites. As of October, 2017, 279 patients had completed the study.

CONCLUSIONS: PERFORM-J is expected to provide valuable information on the longitudinal relationship between cognitive dysfunction, depressive symptoms, and other functional outcomes in Japanese patients with major depressive disorder who initiate monotherapy with antidepressants.

TRIAL REGISTRATION: UMIN Clinical Trials Registry UMIN000024320; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi? recptno=R000028011 (Archived by WebCite at https://www.webcitation.org/70K7W9PgC).

REGISTERED REPORT IDENTIFIER: RR1-10.2196/9682.