Actively Recruiting
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
Eligibility Criteria
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
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
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Withdrawn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Withdrawn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
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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