Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT07046494

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

Led by Rapport Therapeutics Inc. · Updated on 2026-05-12

250

Participants Needed

22

Research Sites

66 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with bipolar I disorder according to DSM-5, with or without psychotic symptoms, confirmed by a structured clinical interview
  • Episode may have mixed features as confirmed by Montgomery-Åsberg Depression Rating Scale
  • Had at least one prior manic episode requiring treatment within 5 years before enrollment
Not Eligible

You will not qualify if you...

  • History of schizophrenia, schizoaffective disorder, major depressive disorder, or moderate to severe substance or alcohol use disorder
  • History of delirium, dementia, amnestic or other cognitive disorders
  • History of borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorders
  • Rapid cycling defined as 4 or more mood episodes in the past 12 months, each separated by at least 2 months remission or switch to opposite polarity

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 22 locations

1

Pillar Clinical Research - Little Rock

Little Rock, Arkansas, United States, 72204

Actively Recruiting

2

Woodland International Research Group

Little Rock, Arkansas, United States, 72211

Withdrawn

3

Woodland Research Northwest

Rogers, Arkansas, United States, 72758

Actively Recruiting

4

Inland Psychiatric Medical Group - Chino

Chino, California, United States, 91710

Active, Not Recruiting

5

Synergy Clinical Research Center - San Diego

Lemon Grove, California, United States, 91945

Actively Recruiting

6

Collaborative Neuroscience Research - Los Alamitos

Los Alamitos, California, United States, 90720

Actively Recruiting

7

NRC Research Institute - Orange

Orange, California, United States, 92868

Actively Recruiting

8

CNRI - San Diego, LLC

San Diego, California, United States, 92123

Withdrawn

9

NeuroBehavioral Hospitals of the Palm Beaches - South

Boynton Beach, Florida, United States, 33426

Actively Recruiting

10

United Research Institute

Hialeah, Florida, United States, 33012

Actively Recruiting

11

CenExel - Hollywood

Hollywood, Florida, United States, 33024

Actively Recruiting

12

Segal Trials - Miami Lakes Medical Research Early Phase, Inpatient & Outpatient Site

Miami Lakes, Florida, United States, 33016

Actively Recruiting

13

Neuroscience Research Institute at Ambrosia

West Palm Beach, Florida, United States, 33407

Actively Recruiting

14

CenExel - Decatur

Decatur, Georgia, United States, 30030

Actively Recruiting

15

Pillar Clinical Research - Chicago

Chicago, Illinois, United States, 60641

Actively Recruiting

16

CenExel - Gaithersburg

Gaithersburg, Maryland, United States, 20877

Active, Not Recruiting

17

Arch Clinical Trials

St Louis, Missouri, United States, 63125

Actively Recruiting

18

Richmond Behavioral Associates

Staten Island, New York, United States, 10314

Actively Recruiting

19

New Hope Clinical Research

Charlotte, North Carolina, United States, 28211

Actively Recruiting

20

Community Clinical Research, Inc.

Austin, Texas, United States, 78754

Actively Recruiting

21

HD Research - Memorial Hermann Village

Houston, Texas, United States, 77043

Actively Recruiting

22

Pillar Clinical Research - Richardson

Richardson, Texas, United States, 75080

Active, Not Recruiting

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Research Team

D

Dawn F Fenton

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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