Table of contents
- Clinical trial overview
- Individual studies and what they measure
- Who can join these trials
- Main endpoints and outcome measures
- Trial design and study groups
- What these trials may mean for patients
Clinical trial overview
The available studies of 9-(4-CYCLOHEXYLOXYPHENYL)-7-METHYL-3,4-DIHYDROPYRAZINO[2,1-C][1,2,4]THIADIAZINE 2,2-DIOXIDE are all in adults with Major Depressive Disorder (MDD).[1] Each listed trial is Phase 3, which means the research is in a later stage and is focused on testing how well the treatment works and how safe it is in larger groups of people.[1]
Across the trials, the study drug is being tested as an adjunctive treatment, which means it is used together with another treatment rather than alone.[1] Some studies compare the drug with placebo, a tablet with no active drug, while one study looks at long-term safety and tolerability without a placebo group.[1]
Individual studies and what they measure
NCT07196501 is a study of maintenance of effect in participants with MDD.[1] Its goal is to see whether the study drug can delay relapse, which means the return of depressive symptoms after improvement.[1] The primary endpoint is the time from randomization to relapse.[1]
NCT06911112, NCT06786624, and NCT06963021 all study the efficacy and safety of adjunctive treatment in adults with MDD.[1] These trials compare the study drug with placebo and measure the change from baseline in total MADRS score at Day 56.[1] MADRS is a depression rating scale used to track symptom severity.[1]
NCT06966401 is a long-term study focused on safety and tolerability in adults with MDD.[1] Its main outcome is the occurrence of adverse events up to Week 52.[1] Adverse events are unwanted medical events that happen during a study, whether or not they are caused by the treatment.[1]
Who can join these trials
The trials listed here are for adults with Major Depressive Disorder.[1] One trial, NCT07196501, specifically includes participants who had a stable response after open-label treatment with the study drug before the randomization step.[1] Open-label treatment means everyone in that first part received the study drug and knew what they were taking.[1]
The source data does not list more detailed eligibility rules, so the main shared target population is adults with MDD.[1]
Main endpoints and outcome measures
The primary endpoint in the relapse study is time from randomization to relapse.[1] This tells researchers how long people stay well before symptoms return.[1]
In the symptom-improvement studies, the main endpoint is change from baseline in total MADRS score at Day 56.[1] “Change from baseline” means the score is compared with the starting score before treatment.[1]
In the long-term safety study, the main endpoint is the occurrence of adverse events up to Week 52.[1] This helps researchers see what happens when the treatment is used for a longer period.[1]
Trial design and study groups
These are interventional trials, which means researchers assign participants to a study treatment and follow what happens.[1] Several studies compare the study drug with a tablet that looks the same but has no active drug, allowing a fair comparison between groups.[1]
The enrollment numbers are different across studies, ranging from 200 participants in some symptom studies to 557 participants in the long-term safety study.[1] The maintenance study plans to enroll 526 participants.[1]
What these trials may mean for patients
For people living with MDD, these studies are trying to answer two main questions: can the treatment improve depression symptoms, and can it help keep symptoms from coming back?[1] The long-term study also asks whether the treatment can be used for a longer time with acceptable safety and tolerability.[1]
Because all listed studies are still in Phase 3 and are authorised, they are part of the later research needed to better understand the role of this treatment in adults with depression.[1]
