Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 2

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

NCT07046494 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • OTHER Placebo
  • DRUG RAP-219

Study Locations (20)

California

  • Inland Psychiatric Medical Group - Chino — Chino
  • Synergy Clinical Research Center - San Diego — Lemon Grove
  • Collaborative Neuroscience Research - Los Alamitos — Los Alamitos
  • NRC Research Institute - Orange — Orange
  • CNRI - San Diego, LLC — San Diego

Florida

  • NeuroBehavioral Hospitals of the Palm Beaches - South — Boynton Beach
  • United Research Institute — Hialeah
  • CenExel - Hollywood — Hollywood
  • Segal Trials - Miami Lakes Medical Research Early Phase, Inpatient & Outpatient Site — Miami Lakes
  • Neuroscience Research Institute at Ambrosia — West Palm Beach

Arkansas

  • Pillar Clinical Research - Little Rock — Little Rock
  • Woodland International Research Group — Little Rock
  • Woodland Research Northwest — Rogers

Georgia

  • CenExel - Decatur — Decatur

Illinois

  • Pillar Clinical Research - Chicago — Chicago

Maryland

  • CenExel - Gaithersburg — Gaithersburg

Missouri

  • Arch Clinical Trials — St Louis

New York

  • Richmond Behavioral Associates — Staten Island

Trial Details

FieldValue
Enrollment Target 224 participants
Start Date 2025-07-25
Est. Completion 2026-12
Phase Phase 2

Sponsor

Rapport Therapeutics

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07046494

The ClinicalTrials.gov registry entry for NCT07046494 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 224 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rapport Therapeutics, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Bipolar 1 Disorder appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07046494 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07046494 about?

NCT07046494 is a clinical study titled "Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Bipolar I Disorder". 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.

What is the current status of trial NCT07046494?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 224 participants. The study started on 2025-07-25. Estimated completion is 2026-12.

What conditions does trial NCT07046494 study?

This clinical trial studies the following conditions: Bipolar 1 Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07046494?

The interventions under investigation include: Placebo (OTHER), RAP-219 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07046494?

This trial is sponsored by Rapport Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07046494 being conducted?

This trial has 20 study locations across Arkansas, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial