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  5. DDT COA #000008: Symptoms of Major Depressive Disorder Scale (SMDDS)
  1. Drug Development Tool Qualification Programs

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

Qualified Clinical Outcome Assessments (COA)
Office of Drug Evaluation (ODE) I
Division of Psychiatry Products (DPP)

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)
Stephen Coons

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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