DDT COA #000008: Symptoms of Major Depressive Disorder Scale (SMDDS)

Qualified Clinical Outcome Assessments (COA)
Office of Neurology (ON)
Division of Psychiatry (DP)

DDT COA Number
DDT COA #000008

Instrument Name
Symptoms of Major Depressive Disorder Scale (SMDDS)

Disease/Condition
Major Depressive Disorder (MDD)

Concept of Interest
Overall symptoms of MDD

Context of Use
Adults (>18 years) with a clinical diagnosis of MDD and:

• treated in an ambulatory setting
• experienced a major depressive episode within the last 6 months
• a HAM-D score > 18 meets the DSM-IV or DSM-V criteria for MDD

COA Type
PRO

Requestor(s)
Critical Path Institute: Patient-Reported Outcome (PRO) Consortium

Contact(s)
Sonya Eremenco

Date Accepted into CDER's COA Qualification Program
September 21, 2010

Qualification Date
November 27, 2017
Qualification Statement

Qualification Supporting Information
Review

Submission and Regulatory Correspondence History

Qualification Submission	Date	FDA Submission Decision & Recommendations	Date
Full Qualification Package	4/12/17	FDA Response (Qualified)	11/27/17

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