Table 1 Relapse definition.

From: Personalized relapse prediction in patients with major depressive disorder using digital biomarkers

Relapse definitions (any of the following)

MADRS37 total score ≥ 22 at a study visit, and a symptom worsening was confirmed during a subsequent Relapse Verification visit over an approximately 1- to 2-week interval

If a patient received a MADRS rating ≥ 22 at a study visit (scheduled or unscheduled), an additional visit (i.e., the Relapse Verification visit) was scheduled within 1 to 2 weeks

• Patients whose MADRS rating was ≥ 22 at the relapse verification visit were considered to have relapsed

OR

• CGI-S38 change from baseline ≥ 2 at the relapse verification visit or medication changes happened during + or − 14 days from the study visit were considered to have relapsed

Hospitalization for worsening of depression

Suicidal ideation with intent, or suicidal behavior

Investigator’s decision (crisis event at the therapy visit, change of medication due to worsening of depression)

  1. CGI-S, the clinical global impression–severity scale; MADRS, montgomery and asberg depression rating scale; crisis event–increased anxiety and depression, feeling sad and crying every day.
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