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A Phase 2, Multicenter, Randomized, Double-blind Evaluation of the Efficacy and Safety of Oral GATE-251 or Placebo for the Reduction of Symptoms of Major Depressive Disorder in Adults

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Trial Profile

A Phase 2, Multicenter, Randomized, Double-blind Evaluation of the Efficacy and Safety of Oral GATE-251 or Placebo for the Reduction of Symptoms of Major Depressive Disorder in Adults

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 07 Apr 2026

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At a glance

  • Drugs Zelquistinel (Primary)
  • Indications Major depressive disorder
  • Focus Therapeutic Use
  • Acronyms VITALIZE
  • Sponsors Syndeio Biosciences

Most Recent Events

  • 20 Mar 2026 Planned End Date changed from 31 Dec 2026 to 1 Dec 2027.
  • 20 Mar 2026 Planned primary completion date changed from 31 Aug 2026 to 1 Sep 2027.
  • 27 May 2025 According to Syndeio Biosciences media release, Gate Neurosciences name changed to Syndeio Biosciences.

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