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RAP-219 for Bipolar I Disorder

This study is testing an investigational drug called RAP-219 to see if it is safe and effective for adults with bipolar I disorder who are experiencing mania. Participants will take either RAP-219 tablets or a placebo (an inactive pill that looks the same) once daily for 21 days. The main goal is to see how RAP-219 affects your mania symptoms, measured by the Young Mania Rating Scale (YMRS) from the start of the study to the end of the 3-week treatment period. You may be able to join if you are between 18 and 65 years old and have a confirmed diagnosis of bipolar I disorder, with or without psychotic symptoms. The current recruitment status is unclear.

Study design
This is a Phase 2, randomized, double-blind, placebo-controlled study with 250 planned participants. It is designed to evaluate RAP-219's efficacy, safety, and tolerability.
What's involved
You would stay in a clinical facility for 3 weeks and take study tablets once daily. Your mania symptoms would be assessed from the start to the end of this 3-week period.
Compensation
Not stated in the trial record.
Follow-up
Your symptoms will be measured up to the end of the 3-week treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07046494

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

Active, Not Recruiting
PHASE2Ages 18–65InterventionalTreatment
Rapport Therapeutics Inc.
~253 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:RAP-219Placebo

At a glance

Recruiting sites
0 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Young Mania Rating Scale (YMRS)
Measured over Baseline to End of Treatment at Week 3

Conditions

Bipolar 1 Disorder

Explore related trials

Bipolar I disorder

Where it's being run

20 sites across 10 states
Florida5
California4
Texas3
Arkansas2
Georgia1
Illinois1
Maryland1
Missouri1

Study leadership

  • Edwin A Gomez, MD · PRINCIPAL_INVESTIGATOR · CenExel Research Centers of America

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Young Mania Rating Scale (YMRS)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.