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A Study to Assess Change in Disease Activity and Adverse Events of Oral Icalcaprant in Adult Participants With Major Depressive Disorder

Evaluating Icalcaprant's effects on depression symptoms and side effects.

Recruiting
18-65 years
All
Phase 2

Major depressive disorder (MDD) is a serious mood problem that makes people feel sad for a long time and lose interest in things they used to enjoy. This study looks at how an investigational drug called Icalcaprant affects people with MDD who are going through a major depressive episode (MDE). An investigational drug is a medicine that is still being tested and is not yet approved for general use. Participants will be split into three groups; one group will receive a placebo, which is a pill with no active medicine, instead of Icalcaprant. About 195 adults will take part, and they will take a pill every day for 6 weeks. Afterward, there will be a 30-day safety check.

  • Participants will have frequent checkups and tests at a hospital or clinic.
  • They will answer questions about how they feel to see if the treatment is working.
  • There might be more work involved than in regular care, including more visits and tests.
Study details
    Major Depressive Disorder

NCT07276997

AbbVie

17 October 2026

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