MADRS as a Clinical Trial Endpoint
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a primary
assessment instrument widely used to measure depression in clinical
trials. The MADRS will often be used in conjunction with the Structured
Interview Guide for the Montgomery-Åsberg Depression Rating Scale
(SIGMA). Thase et al (2021) have reported that MADRS is generally more
sensitive than the HAM-D and is the scale used most often in depression
trials. The MADRS has been the primary endpoint in a number of bipolar
disorder clinical trials, including lumateperone6,
olanzapine plus fluoxetine7,
cariprazine8, quetiapine plus
lithium9, and adjunctive lurasidone
(NCT01284517).10
The MADRS is a 10-item, semi-structured assessment with scores ranging
from 0-6 for each item where 0 represents absence or denial of symptom
and 6 represents the highest symptom severity. The 10-item MADRS/SIGMA
addresses questions related to apparent sadness, reported sadness, inner
tension, reduced sleep, reduced appetite, concentration difficulties,
lassitude, inability to feel, pessimistic thoughts, and suicidal
thoughts. The MADRS is focused on mood symptoms whereas the HAM-D
measures somatic and behavioral symptoms, which have lower
reliability.11 The MADRS also generally takes less
time to administer than the HAM-D, which reduces subject burden.