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

Not Applicable

Recruiting

• Conditions: Bipolar 1 Disorder
• Interventions: Drug: RAP-219; Other: Placebo

• Registration Number: NCT07046494
• Lead Sponsor: Rapport Therapeutics Inc.

Brief 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.

Detailed Description

This is a Phase 2, proof-of-concept, multi-center, randomized, double blind, placebo-controlled study designed to evaluate the efficacy, safety and tolerability of RAP-219 in adult participants experiencing mania associated with bipolar I disorder. This is a 3-week inpatient clinical trial.

Study Timeline

• Study First Submitted: 2025-05-30
• Study First Submitted QC: 2025-06-23
• Status Verified: 2025-07
• Study First Posted: 2025-07-01
• Study Start: 2025-07-25
• Last Update Submitted: 2025-07-29
• Last Update Posted: 2025-08-01
• Primary Completion: 2026-10
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

• Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of bipolar I disorder, with or without mixed features, with or without psychotic symptoms, as confirmed by the Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT)
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Arm	RAP-219	Treatment with RAP-219
Placebo	Placebo	Inert comparator matching the active treatment

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Young Mania Rating Scale (YMRS)	Baseline to End of Week 1	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.
Electrocardiogram (ECG) abnormal findings	Baseline to end of Study Period 8 Weeks after date of last dose	Shift table of normal to abnormal ECG findings
Treatment Emergent Adverse Events (TEAEs)	Baseline to end of Study Period 8 Weeks after date of last dose	Incidence and severity of treatment-emergent adverse events (TEAEs).
Body Temperature	Baseline to end of Study Period 8 Weeks after date of last dose	Change in body temperature
Blood Pressure	Baseline to end of Study Period 8 Weeks after date of last dose	Change in blood pressure (Hg mm)
Laboratory Analytes	Baseline to end of Study Period 8 Weeks after date of last dose	Change in laboratory analytes (absolute value)
Electrocardiogram (ECG) QTc interval	Baseline to end of Study Period 8 Weeks after date of last dose	Changes in electrocardiogram (ECGs); QTc prolongation
Suicidality	Baseline to end of Study Period 8 Weeks after date of last dose	Incidence of suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS).
Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness Mania score	Baseline to end of Treatment at Week 3	The CGI-BP Severity of Illness Mania score is a clinician-rated scale used to assess the severity of manic symptoms, depression and overall illness severity in individuals with bipolar disorder. The mania score ranges from 1 (not ill) to 7 (very severely ill), with higher scores indicating greater severity of manic symptoms.
Heart Rate	Baseline to end of Study Period 8 Weeks after date of last dose	Change in Heart Rate (BPM)
Respiratory Rate	Baseline to end of Study Period 8 Weeks after date of last dose	Change in Respiratory Rate (breaths per minute)

Trial Locations

Locations (1)

CenExel - Gaithersburg; 🇺🇸 Gaithersburg, Maryland, United States