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Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms

Study on Seltorexant for depression and insomnia symptoms.

Recruiting
18-74 years
All
Phase 3

This study is for adults and older people who have major depressive disorder with insomnia symptoms (MDDIS). It tests how well a medicine called **seltorexant** works when added to an antidepressant. **Seltorexant** could help improve depressive symptoms for people who haven't had enough improvement from their current antidepressants, such as SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors). Participants must have tried 1 or 2 antidepressants without complete success but have shown some improvement. They should be taking a stable dose of their current medication. The study excludes those with serious health conditions like recent kidney issues, thyroid problems, or certain other diseases.

  • Participants will need to be on a stable antidepressant for at least 6 weeks before joining.
  • People should be able to safely take the study medicine and follow the study rules.
  • Participants with major health issues or specific conditions like narcolepsy or seizure history cannot join.
Study details
    Depressive Disorder
    Major

NCT06559306

Janssen Research & Development, LLC

4 May 2025

Step 1 Get in touch with the nearest study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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