DDT COA #000109: Symptoms of Major Depressive Disorder Momentary Assessment (SMDDMA)
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Neuroscience (ON)
Division of Psychiatry (DP)
DDT COA Number
DDT COA #000109
Instrument Name
Symptoms of Major Depressive Disorder Momentary Assessment (SMDDMA)
Disease/Condition
Major Depressive Disorder (MDD)
Concept of Interest
Depression symptom severity
Context of Use
Adults with MDD “at this moment”
COA Type
PRO
Qualification Stage
Letter of Intent- Accepted
Requestor(s)
Critical Path Institute: Patient- Reported Outcome (PRO) Consortium, Depression Working Group
Contact(s)
Sonya Eremenco
Date Accepted into CDER’s COA Qualification Program
February 4, 2019
Submission and Regulatory Correspondence History
Qualification Submission |
Date |
FDA Submission Decision & Recommendations |
Date |
---|---|---|---|
11/5/18 |
2/4/19 |