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.