DDT COA #000122: Telemedicine-based Administration of the Montgomery-Asberg Depression Rating Scale (MADRS)

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Neuroscience (ON)
Division of Psychiatry (DPP)

DDT COA Number
DDT COA #000122

Instrument Name
Telemedicine-based Administration of the Montgomery-Asberg Depression Rating Scale (MADRS)

Disease/Condition
Major Depressive Disorder (MDD)

Concept of Interest
Signs and symptoms of depression

Context of Use
Adults (18-65 years) with MDD treated in an ambulatory setting and who have experienced a major depressive episode within the previous 6 months

COA Type
ClinRO

Qualification Stage
Letter of Intent- Not Accepted

Requestor(s)
Science 37

Contact(s)
Lisa DiMolfetto

Date Accepted into CDER’s COA Qualification Program
N/A

Submission and Regulatory Correspondence History

Qualification Submission	Date	FDA Submission Decision & Recommendations	Date
Letter of Intent	10/11/19	FDA Response (Not Accepted)	2/3/20