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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Bipolar I Disorder
Sponsor: Rapport Therapeutics Inc.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
224
Start Date
2025-07-25
Completion Date
2026-12
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
RAP-219
RAP-219 tablets administered orally, once daily for 21 days
Placebo
Matching placebo tablets administered orally, once daily for 21 days
Locations (22)
Pillar Clinical Research - Little Rock
Little Rock, Arkansas, United States
Woodland International Research Group
Little Rock, Arkansas, United States
Woodland Research Northwest
Rogers, Arkansas, United States
Inland Psychiatric Medical Group - Chino
Chino, California, United States
Synergy Clinical Research Center - San Diego
Lemon Grove, California, United States
Collaborative Neuroscience Research - Los Alamitos
Los Alamitos, California, United States
NRC Research Institute - Orange
Orange, California, United States
CNRI - San Diego, LLC
San Diego, California, United States
NeuroBehavioral Hospitals of the Palm Beaches - South
Boynton Beach, Florida, United States
United Research Institute
Hialeah, Florida, United States
CenExel - Hollywood
Hollywood, Florida, United States
Segal Trials - Miami Lakes Medical Research Early Phase, Inpatient & Outpatient Site
Miami Lakes, Florida, United States
Neuroscience Research Institute at Ambrosia
West Palm Beach, Florida, United States
CenExel - Decatur
Decatur, Georgia, United States
Pillar Clinical Research - Chicago
Chicago, Illinois, United States
CenExel - Gaithersburg
Gaithersburg, Maryland, United States
Arch Clinical Trials
St Louis, Missouri, United States
Richmond Behavioral Associates
Staten Island, New York, United States
New Hope Clinical Research
Charlotte, North Carolina, United States
Community Clinical Research, Inc.
Austin, Texas, United States
HD Research - Memorial Hermann Village
Houston, Texas, United States
Pillar Clinical Research - Richardson
Richardson, Texas, United States