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A Study of CLE-100 (oral Esketamine) As an Adjunctive Treatment to Standard Antidepressants for Major Depressive Disorder

Exploring CLE-100 with antidepressants for major depression relief.

Recruiting
18-65 years
All
Phase 2

This study is testing a new medicine called CLE-100, also known as oral esketamine. It's for people with Major Depressive Disorder (MDD), which is a type of depression. This study is for adults aged 18-65 who have tried at least two other depression medicines but didn't get better. For the first 4 weeks, participants will take either CLE-100 or a placebo (a pill with no medicine) along with their current depression medicine. If they do well, they can join a 6-month extension where everyone gets CLE-100.

Key Points:

  • Study Duration: 4 weeks, with an optional 6-month extension.
  • Eligibility: Ages 18-65, diagnosed with MDD, and tried 2+ depression meds without success.
  • Risks: Must not have certain medical conditions or a high risk of suicide.

Participants need to be able to read and sign a consent form. The study checks if CLE-100 works better than a placebo for people who haven't improved with other treatments. If interested, make sure you meet the criteria and understand the risks before joining.

Study details
    Adjunctive Treatment of Major Depressive Disorder (MDD)

NCT06340958

Clexio Biosciences Ltd.

15 March 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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