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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Bipolar I Disorder

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Enrollment closed, study ongoingv15 Show 4 more changesShow less
    • Study completion moved earlier from Nov 2026 to Oct 2026
    • Enrollment target: estimated 250 to confirmed 253
    • Study sites: 22 to 20
    • Primary completion date changed from estimate of Sep 2026 to Aug 5, 2026
  2. Site details revised at 1 of 22 sitesv14
  3. Site details revised at 1 of 22 sitesv13
  4. Site details revised at 2 of 22 sitesv12
  5. Enrollment increased: 224 → 250 participants
    • Primary completion moved earlier from Oct 2026 to Sep 2026
    • Study completion moved earlier from Dec 2026 to Nov 2026
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Site details revised at 1 of 22 sitesv10
  2. Site details revised at 2 of 22 sitesv9
  3. Site details revised at 2 of 22 sitesv8
  4. Site details revised at 6 of 22 sitesv7
  5. Eligibility criteria expanded, about 8 words
    • Secondary endpoints: 11 to 10
    v6
  6. Study sites: 14 to 22v5
  7. Study sites: 11 to 14v4
  8. Study sites: 1 to 11v3
  9. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 2025 to Jul 25, 2025
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a clinical research study for an investigational drug called RAP-219 in participants with bipolar I disorder. This study is being conducted to determine if RAP-219 is safe and effective in participants experiencing mania associated with bipolar I disorder.
Trial Details
NCT Number NCT07046494
Lead Sponsor Rapport Therapeutics Inc.
Conditions
(from sponsor)		 Bipolar 1 Disorder
Related terms Mania
Enrollment 253 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov