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Ademetionine

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

Table of Contents

Clinical trial overview

These studies are testing Ademetionine in people with major depressive disorder and related depression diagnoses.[1][2] Both trials are Phase 3 studies, which means they are testing the treatment in larger groups and comparing it with placebo.[1][2]

One study uses tablets as an add-on to antidepressant treatment, and the other uses intramuscular injection as an add-on to regular antidepressant tablet treatment.[1][2] Both studies are interventional, meaning researchers assign the study treatment and compare outcomes between groups.[1][2]

Who can participate

The tablet study includes patients with major depressive disorder who had an inadequate response to antidepressants and a Hamilton score of 15 to 20, with up to 10% reduction at baseline.[1] The injection study includes subjects with major depression disorders who are already treated regularly with antidepressant tablets.[2]

In simple terms, these trials focus on people whose depression has not improved enough with current treatment.[1][2]

How the studies are designed

The first trial compares Ademetionine tablets with placebo tablets on top of additional antidepressant treatment.[1] The planned enrollment is 600 participants.[1]

The second trial compares Ademetionine injection with placebo injection in people already receiving antidepressant tablets.[2] The planned enrollment is 468 participants.[2]

Both studies are currently Authorised, which means they have been approved to begin or continue according to the source data.[1][2]

What the trials measure

The tablet study measures change from baseline in the HDRS-17 score at Week 6.[1] This score is a standard way to track depression severity over time.[1]

The injection study measures change from baseline in the MADRS score after 7 days of treatment.[2] This is another standard scale used to see whether symptoms improve.[2]

Both trials also aim to evaluate safety while comparing Ademetionine with placebo.[1][2]

Key patient terms

Placebo means a study treatment that looks like the real one but does not contain the active study medicine.[1][2]

Baseline is the starting point before treatment begins, and the studies compare later scores with this starting point.[1][2]

Adjunctive treatment means a treatment given in addition to the usual antidepressant therapy, not instead of it.[1][2]

Hamilton score, HDRS-17, and MADRS are rating tools used to measure how severe depression is and whether it changes during treatment.[1][2]

Trial ID Phase Condition studied Status Enrollment
2024-513019-29-00 Phase 3 Major Depression Disorder Authorised 600
2024-513022-29-00 Phase 3 Major Depression Disorders Authorised 468

FAQ

  • What are the Ademetionine trials studying? They are studying whether Ademetionine, given as tablets or injections, can improve depression symptoms when added to usual antidepressant treatment. The trials also look at safety.
  • Who can take part in these studies? The studies are for people with major depressive disorder or major depression disorders. One trial includes patients with an inadequate response to antidepressants and a Hamilton score between 15 and 20.
  • What phases are the Ademetionine trials? Both trials are Phase 3 studies. This means they are testing the treatment in larger groups of patients to compare it with placebo.
  • What conditions are being studied? The trials focus on major depressive disorder and major depression disorders. They are looking at patients who are already receiving antidepressant treatment.
  • What do the trials measure? One trial measures change in HDRS-17 score after 6 weeks. The other measures change in MADRS score after 7 days. These are standard scales used to rate depression severity.

Ongoing Clinical Trials on Ademetionine

  • Study on the Effectiveness and Safety of Ademetionine Injections for Patients with Major Depressive Disorder Not Responding to Antidepressants

    Recruiting

    1 1 1
    Investigated drugs:
    Italy

  • Study on the Effectiveness and Safety of Ademetionine with Antidepressants for Patients with Major Depressive Disorder

    Recruiting

    1 1 1
    Investigated drugs:
    Italy

Glossary

  • Major depressive disorder (MDD): A common mental health condition with low mood, loss of interest, and other symptoms that last for at least two weeks.
  • Placebo: A treatment that looks like the real study drug but has no active medicine. It is used for comparison.
  • Adjunctive treatment: A treatment added on top of another treatment, rather than used alone.
  • Antidepressant therapy: Treatment with medicines used to help reduce symptoms of depression.
  • Phase 3: A later stage of clinical research where a treatment is tested in larger groups of people.
  • HDRS-17: A 17-item scale used to measure how severe depression symptoms are.
  • MADRS: The Montgomery Asberg Depression Rating Scale, a tool used to measure depression severity and change over time.
  • Baseline: The starting point before treatment begins, used for comparison later.
  • Inadequate response: When symptoms do not improve enough with a treatment that is already being used.
  • Interventional study: A study where researchers give a treatment and compare results between groups.

References

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