In short
Clinical trials are studying 9-(4-CYCLOHEXYLOXYPHENYL)-7-METHYL-3,4-DIHYDROPYRAZINO[2,1-C][1,2,4]THIADIAZINE 2,2-DIOXIDE in adults with Major Depressive Disorder. These studies look at whether it can help improve depression symptoms, delay relapse, and assess safety over time. Most trials are Phase 3 and compare the study drug with placebo.
Key points
- Clinical trials of 9-(4-CYCLOHEXYLOXYPHENYL)-7-METHYL-3,4-DIHYDROPYRAZINO[2,1-C][1,2,4]THIADIAZINE 2,2-DIOXIDE are focused on adults with Major Depressive Disorder. The studies are all Phase 3 and are designed to test whether the treatment helps improve depression symptoms, delay relapse, and stay safe over longer use. Some trials compare the study drug with placebo, while one long-term study looks at safety and tolerability alone. The main symptom measure used is the MADRS score, and one study measures time to relapse. Enrollment ranges from 200 to 557 participants across the listed trials.
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). 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.
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. 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.
Individual studies and what they measure
NCT07196501 is a study of maintenance of effect in participants with MDD. Its goal is to see whether the study drug can delay relapse, which means the return of depressive symptoms after improvement. The primary endpoint is the time from randomization to relapse.
NCT06911112, NCT06786624, and NCT06963021 all study the efficacy and safety of adjunctive treatment in adults with MDD. These trials compare the study drug with placebo and measure the change from baseline in total MADRS score at Day 56. MADRS is a depression rating scale used to track symptom severity.
NCT06966401 is a long-term study focused on safety and tolerability in adults with MDD. Its main outcome is the occurrence of adverse events up to Week 52. Adverse events are unwanted medical events that happen during a study, whether or not they are caused by the treatment.
Who can join these trials
The trials listed here are for adults with Major Depressive Disorder. One trial, NCT07196501, specifically includes participants who had a stable response after open-label treatment with the study drug before the randomization step. Open-label treatment means everyone in that first part received the study drug and knew what they were taking.
The source data does not list more detailed eligibility rules, so the main shared target population is adults with MDD.
Main endpoints and outcome measures
The primary endpoint in the relapse study is time from randomization to relapse. This tells researchers how long people stay well before symptoms return.
In the symptom-improvement studies, the main endpoint is change from baseline in total MADRS score at Day 56. “Change from baseline” means the score is compared with the starting score before treatment.
In the long-term safety study, the main endpoint is the occurrence of adverse events up to Week 52. This helps researchers see what happens when the treatment is used for a longer period.
Trial design and study groups
These are interventional trials, which means researchers assign participants to a study treatment and follow what happens. Several studies compare the study drug with a tablet that looks the same but has no active drug, allowing a fair comparison between groups.
The enrollment numbers are different across studies, ranging from 200 participants in some symptom studies to 557 participants in the long-term safety study. The maintenance study plans to enroll 526 participants.
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? The long-term study also asks whether the treatment can be used for a longer time with acceptable safety and tolerability.
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.