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

NCT07046494 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-05-18

No results posted yet for this study

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.

Conditions

  • Bipolar 1 Disorder

Interventions

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

Sponsors & Collaborators

  • Rapport Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Edwin A Gomez, MD · CenExel Research Centers of America

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-25
Primary Completion
2026-09-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07046494 on ClinicalTrials.gov