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A Phase 1, 2-Part Study to Evaluate the Pharmacokinetics and Safety of SAGE-217 in Adolescents (Part A: 12 to 17 Years of Age) and Children (Part B: 7 to 11 Years of Age) With Major Depressive Disorder

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Trial Profile

A Phase 1, 2-Part Study to Evaluate the Pharmacokinetics and Safety of SAGE-217 in Adolescents (Part A: 12 to 17 Years of Age) and Children (Part B: 7 to 11 Years of Age) With Major Depressive Disorder

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 01 Apr 2025

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At a glance

  • Drugs Zuranolone (Primary)
  • Indications Major depressive disorder
  • Focus Pharmacokinetics
  • Sponsors Biogen; Sage Therapeutics

Most Recent Events

  • 18 Nov 2024 Status changed from active, no longer recruiting to completed.
  • 04 Oct 2024 Planned primary completion date changed from 1 Sep 2024 to 1 Oct 2024.
  • 04 Oct 2024 Status changed from recruiting to active, no longer recruiting.

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