In short
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.
Key points
- Clinical trials are studying Ademetionine in people with major depressive disorder and major depression disorders. Both studies are Phase 3 and compare Ademetionine with placebo while patients continue antidepressant treatment. One trial uses tablets in 600 participants, and the other uses injections in 468 participants. The main goals are to see whether depression symptoms improve and to check safety. The trials use standard rating scales, including HDRS-17 and MADRS, to measure change in symptoms.
Clinical trial overview
These studies are testing Ademetionine in people with major depressive disorder and related depression diagnoses. Both trials are Phase 3 studies, which means they are testing the treatment in larger groups and comparing it with placebo.
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. Both studies are interventional, meaning researchers assign the study treatment and compare outcomes between groups.
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. The injection study includes subjects with major depression disorders who are already treated regularly with antidepressant tablets.
In simple terms, these trials focus on people whose depression has not improved enough with current treatment.
How the studies are designed
The first trial compares Ademetionine tablets with placebo tablets on top of additional antidepressant treatment. The planned enrollment is 600 participants.
The second trial compares Ademetionine injection with placebo injection in people already receiving antidepressant tablets. The planned enrollment is 468 participants.
Both studies are currently Authorised, which means they have been approved to begin or continue according to the source data.
What the trials measure
The tablet study measures change from baseline in the HDRS-17 score at Week 6. This score is a standard way to track depression severity over time.
The injection study measures change from baseline in the MADRS score after 7 days of treatment. This is another standard scale used to see whether symptoms improve.
Both trials also aim to evaluate safety while comparing Ademetionine with placebo.
Key patient terms
Placebo means a study treatment that looks like the real one but does not contain the active study medicine.
Baseline is the starting point before treatment begins, and the studies compare later scores with this starting point.
Adjunctive treatment means a treatment given in addition to the usual antidepressant therapy, not instead of it.
Hamilton score, HDRS-17, and MADRS are rating tools used to measure how severe depression is and whether it changes during treatment.