NCT07046494

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

A Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of RAP-219 for the Acute Treatment of Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: Rapport Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a Phase 2, proof-of-concept, multi-center, randomized, double blind, placebo-controlled study designed to evaluate the efficacy, safety and tolerability of RAP-219 in adult participants experiencing mania associated with bipolar I disorder. This is a 3-week inpatient clinical trial.

Conditions

• Bipolar 1 Disorder

Interventions

Type	Name	Description
DRUG	RAP-219	RAP-219 tablets administered orally, once daily for 21 days
OTHER	Placebo	Matching placebo tablets administered orally, once daily for 21 days

Timeline

• Start date: 2025-07-25
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2025-07-01
• Last updated: 2026-04-02

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study