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

May 29, 2026 updated by: Rapport Therapeutics Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Withdrawn
        • Woodland International Research Group
      • Little Rock, Arkansas, United States, 72204
        • Active, not recruiting
        • Pillar Clinical Research - Little Rock
      • Rogers, Arkansas, United States, 72758
        • Recruiting
        • Woodland Research Northwest
        • Principal Investigator:
          • Robert Billingsley, MD
        • Contact:
          • Robert Billingsley, MD
    • California
      • Chino, California, United States, 91710
        • Active, not recruiting
        • Inland Psychiatric Medical Group - Chino
      • Lemon Grove, California, United States, 91945
        • Recruiting
        • Synergy Clinical Research Center - San Diego
        • Principal Investigator:
          • Charmaine Semeniuk
        • Contact:
          • Charmaine Semeniuk, MD
      • Los Alamitos, California, United States, 90720
        • Recruiting
        • Collaborative Neuroscience Research - Los Alamitos
        • Principal Investigator:
          • David P Walling, PhD
        • Contact:
          • David P Walling, PhD
      • Orange, California, United States, 92868
        • Recruiting
        • NRC Research Institute - Orange
        • Principal Investigator:
          • Daniel Chueh, MD
        • Contact:
          • Daniel Chueh, MD
      • San Diego, California, United States, 92123
        • Withdrawn
        • CNRI - San Diego, LLC
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Recruiting
        • NeuroBehavioral Hospitals of the Palm Beaches - South
        • Principal Investigator:
          • Mohammad Asim Nisar, MD
        • Contact:
          • Mohammad Asim Nisar, MD
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • United Research Institute
        • Contact:
          • Patrick Pinchinat, MD
        • Principal Investigator:
          • Patrick Pinchinat
      • Hollywood, Florida, United States, 33024
        • Recruiting
        • CenExel - Hollywood
        • Principal Investigator:
          • Edwin Gomez, MD
        • Contact:
          • Edwin Gomez, MD
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Segal Trials - Miami Lakes Medical Research Early Phase, Inpatient & Outpatient Site
        • Contact:
          • Rishi Kakar, MD
        • Principal Investigator:
          • Rishi Kakar, MD
      • West Palm Beach, Florida, United States, 33407
        • Recruiting
        • Neuroscience Research Institute at Ambrosia
        • Contact:
          • Danesh Alam, MD
        • Principal Investigator:
          • Danesh Alam, MD
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • CenExel - Decatur
        • Principal Investigator:
          • Kimball Johnson, MD
        • Contact:
          • Kimball Johnson, MD
    • Illinois
      • Chicago, Illinois, United States, 60641
        • Recruiting
        • Pillar Clinical Research - Chicago
        • Principal Investigator:
          • Roueen Rafeyan, MD
        • Contact:
          • Roueen Rafeyan, MD
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • Active, not recruiting
        • CenExel - Gaithersburg
    • Missouri
      • St Louis, Missouri, United States, 63125
        • Recruiting
        • Arch Clinical Trials
        • Contact:
          • Kulsoom Juniad, MD
        • Principal Investigator:
          • Kulsoom Juniad, MD
    • New York
      • Staten Island, New York, United States, 10314
        • Recruiting
        • Richmond Behavioral Associates
        • Contact:
          • Peter Weiden
        • Principal Investigator:
          • Peter Weiden, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Recruiting
        • New Hope Clinical Research
        • Contact:
          • Kurian Abraham, MD
        • Principal Investigator:
          • Kurian Abraham
    • Texas
      • Austin, Texas, United States, 78754
        • Recruiting
        • Community Clinical Research, Inc.
        • Contact:
          • Samuel Collier, MD
        • Principal Investigator:
          • Samuel Collier, MD
      • Houston, Texas, United States, 77043
        • Active, not recruiting
        • HD Research - Memorial Hermann Village
      • Richardson, Texas, United States, 75080
        • Active, not recruiting
        • Pillar Clinical Research - Richardson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of bipolar I disorder, with or without psychotic symptoms, as confirmed by the Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT). Episode may contain mixed features, as confirmed by Montgomery-Åsberg Depression Rating Scale (MADRS).
  • Had at least one prior documented manic episode (with or without psychotic symptoms) that required treatment, within 5 years prior to Visit 1

Exclusion Criteria:

  • History of any of the following diagnoses: a. schizophrenia; schizoaffective disorder; major depressive disorder; moderate or severe substance or alcohol use disorder; as assessed by the SCID-5-CT b. delirium, dementia, amnestic, or other cognitive disorders; borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorders; by medical history and/or Investigator opinion Note: Any other current diagnoses must be discussed with the Medical Monitor.
  • Rapid cycler, defined as experiencing ≥4 distinct mood episodes (ie, manic or depressive) each meeting full DSM-5 criteria in the previous 12 months, and each separated by ≥2 months of full or partial remission, or a switch to an episode of the opposite polarity, as assessed by the SCID-5-CT

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Arm
Treatment with RAP-219
Drug: RAP-219
RAP-219 tablets administered orally, once daily for 21 days
Placebo Comparator: Placebo
Inert comparator matching the active treatment
Other: Placebo
Matching placebo tablets administered orally, once daily for 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Young Mania Rating Scale (YMRS)
Time Frame: Baseline to End of Treatment at Week 3
The YMRS is a clinician administered scale that consists of 11 items used to assess the severity of manic symptoms (total scores range from 0 to 60). The higher the YMRS score, the more severe the subject's symptoms of mania.
Baseline to End of Treatment at Week 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness Mania score
Time Frame: Baseline to end of Treatment at Week 3
The CGI-BP Severity of Illness Mania score is a clinician-rated scale used to assess the severity of manic symptoms, depression and overall illness severity in individuals with bipolar disorder. The mania score ranges from 1 (not ill) to 7 (very severely ill), with higher scores indicating greater severity of manic symptoms.
Baseline to end of Treatment at Week 3
Treatment Emergent Adverse Events (TEAEs)
Time Frame: Baseline to end of Study Period 8 Weeks after date of last dose
Incidence and severity of treatment-emergent adverse events (TEAEs).
Baseline to end of Study Period 8 Weeks after date of last dose
Heart Rate
Time Frame: Baseline to end of Study Period 8 Weeks after date of last dose
Change in Heart Rate (BPM)
Baseline to end of Study Period 8 Weeks after date of last dose
Respiratory Rate
Time Frame: Baseline to end of Study Period 8 Weeks after date of last dose
Change in Respiratory Rate (breaths per minute)
Baseline to end of Study Period 8 Weeks after date of last dose
Body Temperature
Time Frame: Baseline to end of Study Period 8 Weeks after date of last dose
Change in body temperature
Baseline to end of Study Period 8 Weeks after date of last dose
Blood Pressure
Time Frame: Baseline to end of Study Period 8 Weeks after date of last dose
Change in blood pressure (Hg mm)
Baseline to end of Study Period 8 Weeks after date of last dose
Laboratory Analytes
Time Frame: Baseline to end of Study Period 8 Weeks after date of last dose
Change in laboratory analytes (absolute value)
Baseline to end of Study Period 8 Weeks after date of last dose
Electrocardiogram (ECG) QTc interval
Time Frame: Baseline to end of Study Period 8 Weeks after date of last dose
Changes in electrocardiogram (ECGs); QTc prolongation
Baseline to end of Study Period 8 Weeks after date of last dose
Electrocardiogram (ECG) abnormal findings
Time Frame: Baseline to end of Study Period 8 Weeks after date of last dose
Shift table of normal to abnormal ECG findings
Baseline to end of Study Period 8 Weeks after date of last dose
Suicidality
Time Frame: Baseline to end of Study Period 8 Weeks after date of last dose
Incidence of suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS).
Baseline to end of Study Period 8 Weeks after date of last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rapport Therapeutics Inc.

Investigators

  • Principal Investigator: Edwin A Gomez, MD, CenExel Research Centers of America

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

May 30, 2025

First Submitted That Met QC Criteria

June 23, 2025

First Posted (Actual)

July 1, 2025

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAP-219-BPM-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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