Transcript:
Hello, and welcome to NP Psych Navigator’s Clinical Insights series. Today I am pleased to present a review of the Montgomery-Åsberg Depression Rating Scale, or MADRS. I am Tony Amberg. I work as a psychiatric nurse practitioner in private practice in Chicago.
Standardized psychiatric rating scales play an integral role in clinical trials, particularly in subject enrollment, eligibility, and evaluation of patients’ responses to their current therapy.1
The American Psychiatric Association (APA) supports using objective assessment tools for screening and monitoring symptoms over time.2
One commonly used scale in clinical trials is the clinician-rated Montgomery-Åsberg Depression Rating Scale. As we said, it’s known as the MADRS.3
The MADRS is used during drug development and assessment in clinical trials.4
In this video, I will walk you through the MADRS, which is commonly used in clinical trials for major depressive disorder, or MDD, and also for bipolar depression. We will take a deep dive into the 10 items within the scale, discuss its appropriate use and how to interpret the scores, and mention some limitations as well of the scale.
Defining the MADRS
Clinical trials have traditionally relied on clinician-rated instruments to study treatment efficacy.5
One of the most frequently used instruments is the MADRS.5
The MADRS was developed in 1979 by Stuart Montgomery and Marie Åsberg. The scale was validated using comparison to the then gold standard Hamilton Depression Rating Scale (HAM-D).6
This clinician-administered scale was designed to measure depression severity and is especially sensitive to change, such as may be seen in the course of pharmacologic management of MDD.5,6
The interrater reliability of the MADRS is high, meaning that multiple raters' ratings for the same patient-reported symptoms and severity are consistent.7 This is important in clinical trials, which are often conducted across different sites and involve multiple clinician raters.8 The MADRS is now one of the most extensively used instruments in clinical and psychopharmacological depression research to assess severity of depression after a patient has been diagnosed.9
The MADRS is relatively quick to administer, and unlike the HAM-D, it focuses primarily on the core mood symptoms of depression rather than the somatic symptoms of depression.
Structure of the MADRS
The 10 items included in the MADRS are reflective of the core symptoms of depressive illness.6 As you will see, the MADRS items coincide quite clearly with the diagnostic criteria listed in the Diagnostic and Statistical Manual of Mental Disorder, 5th edition.10
The MADRS evaluates 10 items. This table illustrates how these items align with the DSM-5 diagnostic criteria for MDD. Areas that align include apparent or reported sadness or depressed mood; reduced sleep; reduced appetite; concentration difficulties; lack of energy; inability to feel or markedly diminished interest or pleasure; pessimistic thoughts and feelings of worthlessness or guilt; and finally, suicidal thoughts.10
As we can see here, the MADRS does not align 100% with the DSM-5 MDD diagnostic criteria, as illustrated by the item “inner tension” on the MADRS. "Inner tension" conflates anguish, dread, and panic. Additionally, psychomotor agitation or retardation, hyperphagia, and hypersomnia are the DSM-5 diagnostic criteria for MDD, and they are not directly reflected in the MADRS. Montgomery and Åsberg noted that they omitted psychomotor retardation and explain that in their trials, this occurred in relatively few patients.6
Scoring of the MADRS
The 10 items in the MADRS are each scored between 0 and 6. Zero represents normal or baseline, and 6 represents continuous or severe presence of symptoms. Total MADRS scores thus range from 0 to 60. The higher the score, the greater the degree of severity of depressive symptoms in that patient.4
Research practice and clinical reality make it necessary to agree on cut-off values of clinical scales like the MADRS to distinguish patients with mild, moderate, and severe depression.9 It is also important in tracking clinically significant improvement over time.
Scoring categories for the MADRS assessing depressive symptom severity in patients4:
- 0–6: means no or marginal depression
- 7–19: mild depression
- 20–34: moderate depression
- ≥35: severe depression
Understanding the corresponding severity level for a MADRS score range is important in interpreting results obtained from research.4
Changes in scores over time can help to characterize response or remission.
Response has been defined as a reduction of at least 50% from baseline on the total MADRS score in patients with depressive symptoms.11
Remission cut-off values have been offered by various researchers, including ≤ 7, ≤8, and ≤9 in MDD patients.11
There is evidence that an improvement of 2 points or more on the MADRS is considered clinically relevant.12 This is an important point when interpreting results from clinical trials.
Using MADRS Scores in Interpreting Clinical Trial Results
It is necessary to keep in mind what a patient’s total scale score means in terms of depression severity. Viewing tables like these helps clinicians to contextualize the MADRS scores reported in clinical trials with the patients they see in the clinical setting. It also helps to understand how these MADRS score ranges compare to ranges of other scales you may use commonly in your practice, such as the Patient Health Questionnaire, or PHQ-9.
This table shows the MADRS and PHQ-9 cut-offs for no, mild, moderate, and severe depression.
In understanding if these therapies are effective in treating depressive symptoms, researchers need a tool to measure and compare outcomes among patients undergoing different treatments. As the MADRS is especially sensitive in assessing changes in depressive symptoms in such trials, you can think of the MADRS as the “gold standard” clinician rating scale for depression, much like the PHQ-9 is in clinical practice.15
Limitations of the MADRS
Like all tools, the MADRS has limitations.
For instance, atypical depressive symptoms such as hyperphagia and hypersomnia are not included in the MADRS.16
It is also important to remember that the adaptation of the MADRS itself is limited, as it is used in clinical trials and is rarely used in clinical practice.
The NP Psych Navigator website has several pieces that focus on major depressive disorder and bipolar depression as well as a collection of clinical scales that can be helpful.
Conclusion
In conclusion, the MADRS is one of the most extensively used instruments in clinical and psychopharmacological depression research.9
It is important for clinicians to be able to understand and interpret clinical trial results and to apply these results appropriately to clinical practice. Providers should review the baseline MADRS data and see how closely that conforms to the patients that they are treating. Understanding how to contextualize the reported outcome measure is an important part of interpreting trial data.
I hope that this review of the MADRS and its use in major depressive disorder and bipolar depression clinical trials has been helpful and that it will allow you to inform your own practice and patient care.
Thank you for joining me today!
