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Vortioxetine

Clinical trials investigating Vortioxetine are studying how it is used in depression care, especially in people with major depressive disorder or other depressive disorders. These studies look at treatment response, symptom improvement, stopping antidepressants safely, and personalized treatment choices. They include adults with treatment failure or remitted depression.

Table of Contents

Overview of the trials

The trial data show that Vortioxetine is being studied in the setting of depression care, not as a stand-alone drug description. These trials look at how treatment plans work for people with major depressive disorder, other depressive disorders, or depression that is already in remission (meaning symptoms have improved a lot).[1][2][2]

All three trials listed are Phase 3 studies, which are later-stage trials that test treatment strategies in larger groups of people.[1][2][2] The studies are authorised and focus on real treatment questions such as symptom improvement, treatment failure, and stopping antidepressants safely.[1][2][2]

Main studies that include Vortioxetine

One study is a randomised, controlled trial in people with major depressive disorder who had a first-time treatment failure on their first-line treatment.[1] It compares a six-week intensified pharmacological treatment with treatment as usual, and Vortioxetine is one of the medicines used in the intensified treatment arm.[1]

This study measures whether symptoms improve by week 6, using the MADRS total score as the main outcome.[1] MADRS is a scale used to rate how severe depression symptoms are.[1]

A second study looks at the safe discontinuation of antidepressants in people with currently remitted depressive disorders.[2] In this trial, Vortioxetine appears as Brintellix oral drops, which is the product name listed in the source data.[2] The study compares hyperbolic tapering with linear tapering, which are two different ways to lower a medicine dose over time.[2]

The third study is the PREDICT clinical trial, which tests a pharmacogenetic strategy for choosing antidepressants in people with depressive disorder after prior treatment failure.[2] Vortioxetine is listed as Vortioxetina Kern Pharma among many possible antidepressant options in this trial.[2] The goal is to see whether using genetic and clinical data can improve the choice of the next antidepressant treatment.[2]

Who can take part

The first trial includes people with major depressive disorder who had a first-time treatment failure on first-line treatment.[1] This means the first treatment did not work well enough, so a different strategy is being tested.[1]

The second trial includes adults with currently remitted depressive disorders.[2] These are people whose depression is currently controlled well enough that the study can test whether antidepressants can be stopped safely.[2]

The PREDICT trial includes people with depressive disorder who are starting a new antidepressant after prior therapy failure.[2] This trial uses information such as demographic data, clinical history, and other medicines to help guide treatment choice.[2]

What the trials measure

The first study measures the change in depression symptoms from baseline to six weeks, using the MADRS score.[1] It also compares the results between the intensified treatment group and the usual care group, including a subgroup of people with first-time treatment failure.[1]

The discontinuation study measures the proportion of participants who fail to stop the antidepressant or restart it during the 16 weeks after stopping.[2] In simple terms, the trial checks whether people can follow the planned dose reduction and stay off the medicine without needing to go back on it.[2]

The PREDICT trial measures symptom remission using changes in PHQ-9 and MADRS scores after a new antidepressant is started.[2] Symptom remission means depression symptoms improve enough that they are much less of a problem.[2]

Trial phases and status

All three studies are in Phase 3, which usually means the treatment approach is being tested in a larger and more practical patient group.[1][2][2] This phase is often used to confirm whether a strategy works well and to compare it with another standard approach.[1][2][2]

Each trial in the source data is marked Authorised, meaning it has been approved to proceed in the setting described by the record.[1][2][2] The planned enrollment ranges from 150 to 453 participants across the studies.[1][2][2]

What the results may mean

Taken together, these trials show that Vortioxetine is being studied within broader depression treatment strategies rather than as a single isolated question.[1][2][2] The studies look at different patient groups: people with active depression, people with treatment failure, and people whose depression is already in remission.[1][2][2]

They also use different outcome measures, such as depression rating scales and the ability to stop antidepressants successfully.[1][2][2] This helps researchers compare treatment approaches and understand which strategy may work best for different types of patients.[1][2][2]

Trial ID Phase Condition studied Status Enrollment
NCT05973851 Phase 3 Major depressive disorder Authorised 453
2023-509377-23-00 Phase 3 Currently remitted depressive disorders Authorised 150
2025-522967-13-00 Phase 3 Depressive disorder Authorised 240

FAQ

  • What are clinical trials with Vortioxetine studying? The trials are studying how Vortioxetine is used in depression treatment plans. They focus on symptom improvement, treatment response, and how it fits into broader antidepressant strategies.
  • Who may take part in these trials? The trial data include adults with major depressive disorder, depressive disorder, or currently remitted depressive disorders. Some studies focus on people who had treatment failure, while others look at people who are stable and trying to stop antidepressants.
  • What trial phases are shown in the data? The trials listed are Phase 3 studies. This means they are later-stage studies that test how well a treatment strategy works in larger groups of people.
  • What outcomes are being measured in the Vortioxetine trials? The studies measure changes in depression symptom scores, such as MADRS and PHQ-9. One trial also measures whether people can stop antidepressants successfully and avoid restarting them.
  • Is Vortioxetine being studied alone or as part of a broader treatment plan? In the trial data, Vortioxetine appears as one option among several antidepressants in larger treatment strategies. The studies compare different treatment approaches, not only one medicine by itself.

Ongoing Clinical Trials on Vortioxetine

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

    Recruiting

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

  • Safe Discontinuation of Antidepressants in Patients with Remitted Depression: Amitriptyline, Fluoxetine, Paroxetine, and Drug Combination Study

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

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

    Not yet recruiting

    1 1 1 1
    Investigated drugs:
    Spain

Glossary

  • Major depressive disorder: A medical condition with ongoing low mood and loss of interest, often with other symptoms that affect daily life.
  • Depressive disorder: A general term for conditions that cause depression symptoms. It can include different forms of depression.
  • Remitted: A state where depression symptoms have improved a lot or are no longer present in a meaningful way.
  • Interventional study: A clinical trial where researchers actively assign treatments and compare outcomes.
  • Phase 3: A later stage of clinical testing that studies treatment effects in larger groups of people.
  • Enrollment: The number of people planned or included in a study.
  • Primary outcome: The main result researchers are trying to measure in a trial.
  • MADRS: The Montgomery-Åsberg Depression Rating Scale, a score used to measure depression severity.
  • PHQ-9: A short questionnaire used to measure depression symptom severity.
  • Tapering: Slowly lowering a medicine dose over time instead of stopping it all at once.
  • Withdrawal symptoms: Unpleasant symptoms that can happen after lowering or stopping a medicine.
  • Pharmacogenetic strategy: A treatment approach that uses genetic information to help choose the best medicine.

References