In short
Clinical trials are studying SELTOREXANT in adults with major depressive disorder and insomnia symptoms. These studies look at how well it works and how safe it is when used with another antidepressant, including both short-term treatment and longer-term relapse prevention.
Key points
- SELTOREXANT is being studied in adults with major depressive disorder and insomnia symptoms. The main trial is a Phase 3 study with 752 planned participants. Researchers are testing it as add-on treatment with an SSRI or SNRI antidepressant after an incomplete response to current treatment. The study looks at whether SELTOREXANT improves depression scores by Day 43 and whether it helps delay relapse in people who first respond during open-label treatment. It also evaluates short-term and longer-term safety.
Clinical trials overview
The available trial is studying SELTOREXANT in adults with major depressive disorder with insomnia symptoms, also called MDDIS in the study summary. It is designed to see whether SELTOREXANT can help improve depressive symptoms when used together with an SSRI or SNRI antidepressant.
The study also looks at whether SELTOREXANT can help delay relapse, which means symptoms coming back after improvement. The trial includes both short-term testing and a longer maintenance phase.
Who the trial is for
This study is for adult depressed patients with insomnia symptoms who have had an inadequate response to their current SSRI or SNRI antidepressant therapy. In simple terms, this means their current treatment has not helped enough.
The trial summary shows that SELTOREXANT is being studied as an adjunctive therapy, which means it is added to another antidepressant rather than replacing it.
How the study is designed
This is a Phase 3 interventional trial, which means researchers are actively giving study treatment and comparing outcomes in a larger group of people. The study is authorised and plans to enroll 752 participants.
The trial includes a comparison with placebo, which is a look-alike treatment with no active study medicine. The summary also describes an open-label part, where treatment is given in a way that is not blinded, followed by a double-blind maintenance phase.
In a double-blind phase, participants and study staff do not know who is receiving which treatment, which helps reduce bias in the results.
What the researchers measure
The main short-term measure is the change from baseline to Day 43 in the MADRS total score. MADRS is a depression rating scale used to measure how severe depressive symptoms are and whether they improve.
The longer-term measure is the time from randomization to the first relapse during the double-blind maintenance phase in participants who had a stable response after open-label SELTOREXANT treatment. This tells researchers how long symptom improvement lasts before depression returns.
The study summary says the trial is also evaluating safety for both short- and long-term use when SELTOREXANT is taken with another antidepressant.
Trial status and size
The trial status is listed as Authorised. The planned enrollment is 752 participants, which suggests a large Phase 3 study.
The registered trial ID is 2023-509070-36-00.
Key terms explained
Randomization means participants are assigned to a study group by chance, so the groups can be compared fairly.
Open-label means everyone knows what treatment is being given during that part of the study.
Maintenance phase means a later part of the study that checks whether benefits last over time.
Relapse means symptoms return after they had improved.