Europas førende søgning efter kliniske forsøg

Ademetionine

Clinical trials are studying Ademetionine in people with major depressive disorder. These studies look at whether it can improve depression symptoms and whether it is safe when added to standard antidepressant treatment. The trials include adults with an inadequate response to antidepressants.

Table of contents

Trial overview

Two authorised Phase 3 studies are investigating Ademetionine in people with major depressive disorder.[1][2] Both studies compare Ademetionine with placebo, which is a look-alike treatment without the active study drug.[1][2]

These studies are interventional, which means researchers give the treatment and then compare results between groups.[1][2] The main goal is to see whether Ademetionine improves depression symptoms when it is added to regular antidepressant treatment.[1][2]

Tablet study in major depressive disorder

One study tests Ademetionine tablets as an add-on treatment in patients with major depressive disorder who have had an inadequate response to antidepressants.[1] The study plans to enroll 600 participants.[1]

The trial compares Samyr® tablets with placebo tablets while participants continue additional antidepressant treatment.[1] The brief summary says the study focuses on people with a Hamilton score of 15-20 and up to 10% reduction at baseline.[1]

The main endpoint is the change in HDRS-17 score from baseline to week 6.[1] HDRS-17 is a depression rating scale used to track how symptoms change over time.

Injection study in major depressive disorder

The second study tests Ademetionine injection given intramuscularly, which means by injection into a muscle.[2] It compares Ademetionine injection with placebo injection in people with depression who are already treated regularly with antidepressant tablets.[2]

This study plans to enroll 468 participants.[2] Its brief summary says Ademetionine is being studied as an enhancer add-on to antidepressant therapy.[2]

The main endpoint is the change from baseline in MADRS score after 7 days of treatment.[2] MADRS is another scale used to measure the severity of depression symptoms and whether they improve.

Who can participate

Based on the trial data, the studies are aimed at adults with major depressive disorder whose symptoms have not improved enough with antidepressant treatment.[1][2] One study gives more detail by naming participants with a Hamilton score of 15-20.[1]

  • Tablet study: people with major depressive disorder and an inadequate response to antidepressants.[1]

  • Injection study: people with depression who are already receiving regular antidepressant tablet treatment.[2]

What is being measured

The studies focus on symptom change, meaning whether depression scores get better after treatment starts.[1][2] They also evaluate safety, which means how well the treatment is tolerated in the study setting.[1][2]

  • HDRS-17 change at week 6: used in the tablet study to see whether symptoms improve over 6 weeks.[1]

  • MADRS change at day 7: used in the injection study to see whether symptoms improve after 7 days.[2]

Terms explained

Baseline means the starting measurement before treatment begins.[1][2] It is used to compare later results with the first study visit.

Enrollment is the number of people planned for a study.[1][2] In these trials, the planned enrollment is 600 in the tablet study and 468 in the injection study.[1][2]

Placebo helps researchers tell whether improvements are likely due to the study treatment rather than chance or expectations.[1][2]

Trial ID Phase Condition studied Status Enrollment
2024-513019-29-00 Phase 3 Major depressive disorder Authorised 600
2024-513022-29-00 Phase 3 Major depressive disorder Authorised 468

FAQ

  • What are the Ademetionine trials trying to find out? They are checking whether Ademetionine works better than placebo when added to regular antidepressant treatment. They also measure safety.
  • Who can take part in these studies? The studies focus on people with major depressive disorder who still have symptoms despite antidepressant treatment. One study includes people with a Hamilton score of 15-20.
  • What trial phases are these studies? Both studies are Phase 3 trials. This means they test how well the treatment works in larger groups of patients.
  • How is Ademetionine being given in these trials? One study uses Ademetionine tablets by mouth. The other study uses Ademetionine injection given into the muscle.
  • What outcomes are being measured? One study measures change in the HDRS-17 score after 6 weeks. The other measures change in the MADRS score after 7 days.

Igangværende kliniske forsøg for Ademetionine

  • Undersøgelse af Samyr-injektioner som tillægsbehandling hos patienter med svær depression, der ikke har tilstrækkelig effekt af deres antidepressive medicin

    Rekrutterer

    1 1 1
    Undersøgte lægemidler:
    Italien

  • Undersøgelse af om Samyr tabletter kan hjælpe personer med depression, når almindelig antidepressiv medicin ikke virker godt nok

    Rekrutterer

    1 1 1
    Undersøgte lægemidler:
    Italien

Ordliste

  • Major depressive disorder (MDD): A medical condition with ongoing low mood and other depression symptoms that affect daily life.
  • Placebo: A look-alike treatment with no active study drug. It helps researchers compare results fairly.
  • Adjunctive treatment: A treatment added on top of another treatment, such as Ademetionine added to antidepressants.
  • Phase 3: A later stage of clinical research that tests how well a treatment works and checks safety in larger groups.
  • Interventional study: A study where researchers give a treatment and then compare outcomes between groups.
  • HDRS-17: A 17-item depression rating scale used to measure symptom severity and change over time.
  • MADRS: A depression rating scale used to measure how severe symptoms are and whether they improve.
  • Baseline: The starting point before treatment begins, used for comparison later.
  • Enrollment: The number of participants planned for a study.
  • Intramuscular use: A treatment given by injection into a muscle.

Referencer

  1. https://clinicaltrials.gov/study/2024-513019-29-00
  2. https://clinicaltrials.gov/study/2024-513022-29-00