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RAP-219 for treating mania in adults with Bipolar I disorder

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

Phase 2 Interventional Rapport Therapeutics Inc. · NCT07046494

This 3-week inpatient trial will test whether RAP-219 reduces mania symptoms in adults hospitalized for an acute manic episode of bipolar I disorder.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment250 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorRapport Therapeutics Inc. Industry-sponsored
Locations22 sites (Little Rock, Arkansas and 21 other locations)
Trial IDNCT07046494 on ClinicalTrials.gov

What this trial studies

This Phase 2, proof-of-concept, randomized, double-blind, placebo-controlled study compares RAP-219 to placebo in adults experiencing mania related to bipolar I disorder. Participants are hospitalized and dosed over a 3-week inpatient period with regular assessments of symptom change, safety, and tolerability. Eligibility requires a DSM-5 diagnosis of bipolar I disorder confirmed by SCID-5-CT and a documented prior manic episode within five years, while key exclusions include schizophrenia-spectrum disorders, major depressive disorder, moderate/severe substance use disorder, and certain personality or cognitive disorders. Efficacy will be measured using standardized mania rating scales with continuous safety monitoring throughout the trial.

Who should consider this trial

Good fit: Adults with a DSM-5 diagnosis of bipolar I disorder who are currently experiencing an acute manic episode requiring inpatient care and who meet the study's inclusion and exclusion criteria would be ideal candidates.

Not a fit: People with primary schizophrenia-spectrum diagnoses, major depressive disorder, moderate or severe substance or alcohol use disorder, certain personality or cognitive disorders, or those unwilling or unable to be hospitalized for three weeks are unlikely to qualify or receive benefit from participation.

Why it matters

Potential benefit: If successful, RAP-219 could offer a new, effective, and well-tolerated treatment option for adults experiencing acute manic episodes of bipolar I disorder.

How similar studies have performed: While established antipsychotics and mood stabilizers have demonstrated efficacy for acute mania, RAP-219 is a novel investigational agent and its clinical effectiveness has not yet been established in prior trials.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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 this trial is running

Little Rock, Arkansas and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Bipolar 1 DisorderBipolarManiaAcuteIn-patientManic StateManic EpisodeMixed Features
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.