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Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD

Evaluating COMP360's effects on treatment-resistant depression (TRD) patients.

Recruiting
18 years and older
All
Phase 3
  • Simplified description (AI rewritten)
  • Technical description (Original)

Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD

This study looks at how well a treatment called COMP360 works for adults with treatment-resistant depression (TRD). TRD means the depression hasn’t improved after trying 2-4 different medicines. The study lasts about 62 weeks, with three parts: Part A (6 weeks), Part B (20 weeks), and Part C (26 weeks). In Part A, participants get either COMP360 or a placebo (a fake treatment) to see if it reduces depression symptoms. Part B checks if the treatment’s effects last and if it’s safe to use again. Part C is an open-label part where everyone knows they’re getting the actual treatment.

  • The study involves 255 adults aged 18 and older.
  • Participants will be randomly assigned to receive COMP360 or placebo.
  • Participants must agree to stop certain medications before joining.

People cannot join if they have other serious mental health conditions like bipolar disorder, schizophrenia, or have had certain treatments like electroconvulsive therapy recently. Participants will receive regular psychological support during the study. 😊

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Study details
    Treatment Resistant Depression

NCT05624268

COMPASS Pathways

8 July 2024

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