In honor of Mental Health Awareness Month 2024, we will be examining the most recent guidelines on major depressive disorder (MDD). Surprisingly, there are not many US-based guidelines for the management of MDD. The most recent guideline was actually published by the Department of Veterans Affairs and the Department of Defense (VA/DoD) in April 2022. Since that time, there have been FOUR new medications approved for patients with Major Depressive Disorder. This post will take a look at what has changed since then, and what the next Clinical Practice Guidelines for MDD may look like after those recent FDA medication approvals. 

Part 1 – Current MDD Guidelines

To start, here is a listing of the current major depressive disorder guidelines in the US:

Other guidelines that deal with depression, but not necessarily MDD include:

Part 2 – FDA Approvals Since The Most Recent Guidelines

The medications/therapies that have been approved by the FDA since the last MDD clinical guideline published in April 2022:

Rejoyn Prescription App for iTunes and Google Play
Otsuka / Click Therapeutics
Approved April 2024
Treatment of major depressive disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD age 22 years and older who are on antidepressant medication

Gepirone (Exxua)
Fabre-Kramer Pharmaceutical
Approved September 2023
To treat major depressive disorder

Cariprazine (Vraylar)
AbbVie
Approved December 2022
adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults

Bupropion/dextromethorphan (Auvelity)
Axsome Therapeutics
Approved August 2022
For the treatment of major depressive disorder (MDD) in adults

And these medications were also approved shortly before the 2022 guideline:

Lumateperone (Caplyta)
Intra-Cellular Therapies
Approved December 2021
Treatment of adults with depressive episodes associated with bipolar I and II disorder, as monotherapy or adjunctive therapy with lithium or valproate

Esketamine (Spravato)
Janssen
Approved August 2020
To treat depressive symptoms in adults with major depressive disorder (MDD) and acute suicidal ideation or behavior

Part 3 – Predictions


Now that we’ve covered the listing of current MDD guidelines, as well as the new FDA approvals and “what’s changed since” the last major depressive disorder guidelines were published, we can jump into the predictions. This is a list of predictions focused specifically on treatment of MDD, and mainly on pharmacological treatment in adults. Also, this isn’t a prediction for a specific guideline or specific organization – these are broad predictions covering the next guideline(s) on the topic, regardless of which organization produces them.

Prediction 1
We believe there will be a greater emphasis on shared decision making for patients with MDD. This is a trend across all areas of medicine, and the emphasis on SDM for MDD seems all but a given. We figured we would start off our predictions with what we think will be an easy one!

Prediction 2
If the next MDD guidelines publish in the next 18 months, we predict that there will not be any recommendation “for” OR any recommendation “against” the recently approved Rejoyn prescription app. However, if the next guideline comes in 2026 or later, there will likely be a “for” recommendation. Given how new the concept of an FDA-approved mobile app is, we predict there may be some hesitancy to provide a “for” recommendation until sufficient data has been collected over time.

Prediction 3
There will be a new “for” recommendation included for cariprazine (Vraylar).

Prediction 4
We predict recommendation(s) endorsing earlier usage of esketamine (Spravato). The current VA/DoD guidelines recommend against esketamine, except as a suggested option for patients who have not responded to several adequate pharmacologic trials. However, we’re predicting that the next guidelines will include a stronger “for” recommendation and will also specify that it can be used earlier in the presence of suicidal thoughts or actions (and not just multiple failed trials with other medications.

Prediction 5
There will be a new “for” recommendation included for bupropion/dextromethorphan (Auvelity).

Prediction 6
Rather than a single guideline for major depressive disorder, we may see multiple MDD guidelines that deal with special populations and/or co-occurring disorders, such as patients with suicidal thoughts.

There you have it – an overview of the current MDD guidelines, what major changes and FDA approvals have happened since, and our informal predictions for what the next guidelines on major depressive disorder may include. Once the next MDD guideline update happens, we will compare our predictions to reality to see how we scored. Here’s hoping for a 5 out of 5!

Do you agree with our predictions? Do you think we missed anything? And is there another topic you would like to see covered in a future guideline predictions series article? Contact us today and let us know!

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