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SELTOREXANT

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.

Table of contents

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.[1] It is designed to see whether SELTOREXANT can help improve depressive symptoms when used together with an SSRI or SNRI antidepressant.[1]

The study also looks at whether SELTOREXANT can help delay relapse, which means symptoms coming back after improvement.[1] The trial includes both short-term testing and a longer maintenance phase.[1]

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.[1] 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.[1]

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.[1] The study is authorised and plans to enroll 752 participants.[1]

The trial includes a comparison with placebo, which is a look-alike treatment with no active study medicine.[1] 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.[1]

In a double-blind phase, participants and study staff do not know who is receiving which treatment, which helps reduce bias in the results.[1]

What the researchers measure

The main short-term measure is the change from baseline to Day 43 in the MADRS total score.[1] 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.[1] 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.[1]

Trial status and size

The trial status is listed as Authorised.[1] The planned enrollment is 752 participants, which suggests a large Phase 3 study.[1]

The registered trial ID is 2023-509070-36-00.[1]

Key terms explained

Randomization means participants are assigned to a study group by chance, so the groups can be compared fairly.[1]

Open-label means everyone knows what treatment is being given during that part of the study.[1]

Maintenance phase means a later part of the study that checks whether benefits last over time.[1]

Relapse means symptoms return after they had improved.[1]

Trial ID Phase Condition studied Status Enrollment
2023-509070-36-00 Phase 3 Major Depressive Disorder with Insomnia Symptoms Authorised 752

FAQ

  • What is being studied in SELTOREXANT trials? The trials are testing whether SELTOREXANT can improve depressive symptoms and help delay relapse. They also look at safety during short-term and longer-term use.
  • Who can take part in these studies? The trial is for adults with major depressive disorder and insomnia symptoms. Participants also had an inadequate response to their current SSRI or SNRI antidepressant.
  • What phase is the SELTOREXANT study? The study is a Phase 3 trial. Phase 3 studies usually include many participants and compare a treatment with placebo to better understand benefit and safety.
  • What condition is the trial focused on? The main condition is major depressive disorder with insomnia symptoms. The study also focuses on depressive symptoms that have not improved enough with current antidepressant treatment.
  • What outcomes are the researchers measuring? The study measures change in depression scores and the time until relapse. These outcomes help show whether SELTOREXANT improves symptoms and keeps them from returning.

Ongoing Clinical Trials on SELTOREXANT

  • Study on Seltorexant for Adults and Elderly with Major Depressive Disorder and Insomnia Symptoms

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia Italy Poland Portugal Romania +3

Glossary

  • Major Depressive Disorder: A mental health condition with persistent low mood and other symptoms that affect daily life.
  • Insomnia Symptoms: Trouble sleeping, such as difficulty falling asleep, staying asleep, or waking too early.
  • Adjunctive therapy: A treatment used together with another treatment, not by itself.
  • SSRI: A type of antidepressant medicine. The trial says SELTOREXANT is studied together with an SSRI in some participants.
  • SNRI: Another type of antidepressant medicine. The trial says SELTOREXANT is studied together with an SNRI in some participants.
  • Placebo: A look-alike treatment with no active study medicine. It helps researchers compare results fairly.
  • Randomization: A process where participants are assigned to a study group by chance.
  • Double-blind: A study design where participants and study staff do not know who gets which treatment.
  • Relapse: When symptoms return after a period of improvement.
  • MADRS total score: A depression rating score used to measure how severe depressive symptoms are and how they change over time.

References

  1. https://clinicaltrials.gov/study/2023-509070-36-00