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Agomelatine

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.

Table of contents

Trial overview

The trial data provided include two Phase 3 studies of Agomelatine in people with depressive disorders.[1][2] Both studies are interventional trials, which means researchers are testing treatment strategies and measuring the results in patients.[1][2]

One study focuses on people with major depressive disorder who had a first-time failure of their first-line treatment.[1] The other study looks at people with depressive disorder who are starting a new antidepressant after prior treatment failure.[2]

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.[1] This makes the study especially relevant for patients whose first antidepressant plan did not work well enough.[1]

The second study includes patients with depressive disorder who are initiating a new therapy after failure of the prior therapy at study entry.[2] It also uses clinical, demographic, and medication data, along with genetic information, to guide treatment selection.[2]

Treatments being tested

In the first trial, Agomelatine appears among many antidepressant and related treatment options used in an early intensified pharmacological treatment strategy.[1] The study compares this intensified approach with treatment as usual, often shortened to TAU, which means the standard care patients would normally receive.[1]

The first study lists many medicines in the treatment options, including Agomelatine, escitalopram, sertraline, venlafaxine, duloxetine, mirtazapine, and others.[1] It also includes ketamine and esketamine in some forms, showing that the study is exploring different treatment paths for difficult-to-treat depression.[1]

In the second trial, Agomelatine is one of several antidepressant choices considered within a pharmacogenetic strategy.[2] A pharmacogenetic strategy uses genetic testing to help choose a treatment that may fit the patient better.[2]

Outcomes being measured

The first trial’s main outcome is the change in symptom severity at six weeks, measured by the MADRS total score.[1] MADRS is a depression rating scale used to show how strong the symptoms are.[1]

This study compares results between the early intensified pharmacological treatment group and the treatment-as-usual group.[1] It also looks at the results separately for treatment lines and for the whole group.[1]

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.[2] Remission means the symptoms have improved a lot, often to a low or minimal level.[2]

Trial phases and status

Both trials are listed as Authorised.[1][2] 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.[1][2]

NCT05973851 plans to enroll 453 participants.[1] The PREDICT clinical trial, listed as 2025-522967-13-00, plans to enroll 240 participants.[2]

What these trials mean for patients

These studies are not mainly asking whether Agomelatine works by itself in a simple way.[1][2] Instead, they study how Agomelatine fits into broader treatment plans for depression, especially when the first treatment has not worked well enough.[1][2]

For patients, the main message is that the research is focused on finding better ways to choose and compare antidepressant treatment strategies.[1][2] The trials use symptom scores and remission rates to see which approach gives the best improvement in depression symptoms.[1][2]

Trial ID Phase Condition studied Status Enrollment
NCT05973851 Phase 3 Major depressive disorder Authorised 453
2025-522967-13-00 Phase 3 Depressive disorder Authorised 240

FAQ

  • What are the Agomelatine trials trying to find out? They are looking at whether Agomelatine helps improve depression symptoms and whether it works well in people who need a new antidepressant after treatment failure.
  • Who may be included in these studies? The trials focus on people with major depressive disorder or depressive disorder. One study especially looks at people who had a first-time failure with their first-line treatment.
  • What phase are the Agomelatine trials in? The trial data shown here are Phase 3 studies. Phase 3 means the treatment strategy is being tested in larger patient groups to measure benefit more clearly.
  • What outcomes are being measured? The studies measure changes in depression severity and remission. Tools used include the MADRS and PHQ-9 scores, which are standard ways to rate depression symptoms.
  • Is Agomelatine being studied alone or with other treatments? In the trial data provided, Agomelatine is one of several antidepressant options being used in treatment strategies. The studies compare different approaches rather than only one drug.

Ongoing Clinical Trials on Agomelatine

  • Study on the Effect of Ketamine and Esketamine in Patients with Major Depressive Disorder After First-Line Treatment Failure

    Recruiting

    3 1 1 1
    Investigated drugs:
    Austria Germany Greece Italy Spain

  • Testing a Pharmacogenetic-Guided Treatment Selection Strategy with Antidepressant Drug Combination for Patients with Depressive Disorder

    Not yet recruiting

    3 1 1 1
    Investigated drugs:
    Spain

Glossary

  • Major depressive disorder: A serious mood disorder with low mood, loss of interest, and other symptoms that affect daily life.
  • Depressive disorder: A general term for conditions where depression symptoms are present.
  • Phase 3: A later stage of clinical research where a treatment is tested in larger groups of patients to see how well it works.
  • Interventional study: A clinical trial where researchers assign a treatment or strategy and then measure the results.
  • Enrollment: The number of people planned or included in a trial.
  • Primary outcome: The main result researchers want to measure in a trial.
  • MADRS: Montgomery Åsberg Depression Rating Scale, a score used to measure how severe depression symptoms are.
  • PHQ-9: A short questionnaire used to measure depression severity.
  • Remission: A state where depression symptoms are much better or may no longer meet the usual level for active illness.
  • First-line treatment failure: When the first treatment tried does not work well enough.
  • Pharmacogenetic strategy: A treatment approach that uses genetic testing to help choose the best medicine.
  • Biomarker: A measurable sign in the body that may help predict how a person will respond to treatment.

References