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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Bipolar 1 Disorder

In brief

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.

Key facts

Study ID

NCT07046494

Run by

Rapport Therapeutics Inc.

People needed

250

Starts

2025-07-25

Expected to finish

2026-11-01

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pillar Clinical Research - Little Rock — Little Rock, Arkansas, United States (enrolling)
• CenExel - Decatur — Decatur, Georgia, United States (enrolling)
• Pillar Clinical Research - Chicago — Chicago, Illinois, United States (enrolling)
• Arch Clinical Trials — St Louis, Missouri, United States (enrolling)
• Richmond Behavioral Associates — Staten Island, New York, United States (enrolling)
• New Hope Clinical Research — Charlotte, North Carolina, United States (enrolling)
• Community Clinical Research, Inc. — Austin, Texas, United States (enrolling)
• Woodland Research Northwest — Rogers, Arkansas, United States (enrolling)
• Synergy Clinical Research Center - San Diego — Lemon Grove, California, United States (enrolling)
• Collaborative Neuroscience Research - Los Alamitos — Los Alamitos, California, United States (enrolling)
• NRC Research Institute - Orange — Orange, California, United States (enrolling)
• NeuroBehavioral Hospitals of the Palm Beaches - South — Boynton Beach, Florida, United States (enrolling)
• United Research Institute — Hialeah, Florida, United States (enrolling)
• CenExel - Hollywood — Hollywood, Florida, United States (enrolling)
• Segal Trials - Miami Lakes Medical Research Early Phase, Inpatient & Outpatient Site — Miami Lakes, Florida, United States (enrolling)
• Neuroscience Research Institute at Ambrosia — West Palm Beach, Florida, United States (enrolling)
• Woodland International Research Group — Little Rock, Arkansas, United States
• CNRI - San Diego, LLC — San Diego, California, United States
• Inland Psychiatric Medical Group - Chino — Chino, California, United States
• Pillar Clinical Research - Richardson — Richardson, Texas, United States
• CenExel - Gaithersburg — Gaithersburg, Maryland, United States
• HD Research - Memorial Hermann Village — Houston, Texas, United States

Full record on ClinicalTrials.gov

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