In short
Clinical trials of Agomelatine are studying how it performs in people with depressive disorders, especially after a first treatment failure. These studies look at outcomes such as symptom improvement, remission, and how Agomelatine compares with other treatment strategies.
Key points
- Clinical trials of Agomelatine in the provided data are focused on depressive disorders, especially major depressive disorder and depressive disorder. Both studies are Phase 3 and are designed as interventional trials. One trial compares an early intensified treatment approach with usual care in people who had a first treatment failure, while the other tests a pre-emptive pharmacogenetic strategy for choosing antidepressants after prior treatment failure. The main outcomes are changes in depression severity and symptom remission, measured with tools such as MADRS and PHQ-9. These trials include adults needing a new treatment plan after their first therapy did not work well.
Trial overview
The trial data provided include two Phase 3 studies of Agomelatine in people with depressive disorders. Both studies are interventional trials, which means researchers are testing treatment strategies and measuring the results in patients.
One study focuses on people with major depressive disorder who had a first-time failure of their first-line treatment. The other study looks at people with depressive disorder who are starting a new antidepressant after prior treatment failure.
Who is being studied
The first study includes subjects with major depressive disorder and specifically mentions a subgroup of people who had their first treatment failure on the first-line treatment. This makes the study especially relevant for patients whose first antidepressant plan did not work well enough.
The second study includes patients with depressive disorder who are initiating a new therapy after failure of the prior therapy at study entry. It also uses clinical, demographic, and medication data, along with genetic information, to guide treatment selection.
Treatments being tested
In the first trial, Agomelatine appears among many antidepressant and related treatment options used in an early intensified pharmacological treatment strategy. The study compares this intensified approach with treatment as usual, often shortened to TAU, which means the standard care patients would normally receive.
The first study lists many medicines in the treatment options, including Agomelatine, escitalopram, sertraline, venlafaxine, duloxetine, mirtazapine, and others. It also includes ketamine and esketamine in some forms, showing that the study is exploring different treatment paths for difficult-to-treat depression.
In the second trial, Agomelatine is one of several antidepressant choices considered within a pharmacogenetic strategy. A pharmacogenetic strategy uses genetic testing to help choose a treatment that may fit the patient better.
Outcomes being measured
The first trial's main outcome is the change in symptom severity at six weeks, measured by the MADRS total score. MADRS is a depression rating scale used to show how strong the symptoms are.
This study compares results between the early intensified pharmacological treatment group and the treatment-as-usual group. It also looks at the results separately for treatment lines and for the whole group.
The second trial measures symptom remission, based on changes in depression severity scores such as PHQ-9 and MADRS after the new antidepressant is started. Remission means the symptoms have improved a lot, often to a low or minimal level.
Trial phases and status
Both trials are listed as Authorised. In the data provided, both are also Phase 3 studies, which are usually done in larger groups to better understand how well a strategy works.
NCT05973851 plans to enroll 453 participants. The PREDICT clinical trial, listed as 2025-522967-13-00, plans to enroll 240 participants.
What these trials mean for patients
These studies are not mainly asking whether Agomelatine works by itself in a simple way. Instead, they study how Agomelatine fits into broader treatment plans for depression, especially when the first treatment has not worked well enough.
For patients, the main message is that the research is focused on finding better ways to choose and compare antidepressant treatment strategies. The trials use symptom scores and remission rates to see which approach gives the best improvement in depression symptoms.