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A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With Major Depressive Episodes Associated With Bipolar I Disorder

Trial Profile

A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With Major Depressive Episodes Associated With Bipolar I Disorder

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 13 May 2026

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At a glance

  • Drugs Amisulpride (Primary)
  • Indications Bipolar I disorders; Major depressive disorder
  • Focus Therapeutic Use
  • Acronyms ILLUMINATE-1
  • Sponsors LB Pharmaceuticals

Most Recent Events

  • 26 Jan 2026 Status changed from planning to recruiting.
  • 26 Jan 2026 According to LB Pharmaceuticals media release, the company announced initiation of Phase 2 bipolar depression trial initiation follows positive Phase 2 results in acute schizophrenia, topline data expected in 1Q 2028. The trial will enroll at approximately 30 sites in the U.S.
  • 18 Nov 2025 New trial record

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