NCT07046494

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for phase_2

Timeline
6mo left

Started Jul 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

22 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Jul 2025Dec 2026

First Submitted

Initial submission to the registry

May 30, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
24 days until next milestone

Study Start

First participant enrolled

July 25, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

May 30, 2025

Last Update Submit

April 29, 2026

Conditions

Bipolar 1 Disorder

Keywords

BipolarManiaAcuteIn-patientManic StateManic EpisodeMixed FeaturesEpisode with Mixed FeaturesMixed ManiaBipolar Episode

Outcome Measures

Primary Outcomes (1)

  • Young Mania Rating Scale (YMRS)

    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.

    Baseline to End of Treatment at Week 3

Secondary Outcomes (10)

  • Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness Mania score

    Baseline to end of Treatment at Week 3

  • Treatment Emergent Adverse Events (TEAEs)

    Baseline to end of Study Period 8 Weeks after date of last dose

  • Heart Rate

    Baseline to end of Study Period 8 Weeks after date of last dose

  • Respiratory Rate

    Baseline to end of Study Period 8 Weeks after date of last dose

  • Body Temperature

    Baseline to end of Study Period 8 Weeks after date of last dose

  • +5 more secondary outcomes

Study Arms (2)

Active Arm

EXPERIMENTAL

Treatment with RAP-219

Drug: RAP-219

Placebo

PLACEBO COMPARATOR

Inert comparator matching the active treatment

Other: Placebo

Interventions

RAP-219DRUG

RAP-219 tablets administered orally, once daily for 21 days

Active Arm
PlaceboOTHER

Matching placebo tablets administered orally, once daily for 21 days

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Pillar Clinical Research - Little Rock

Little Rock, Arkansas, 72204, United States

RECRUITING

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

WITHDRAWN

Woodland Research Northwest

Rogers, Arkansas, 72758, United States

RECRUITING

Inland Psychiatric Medical Group - Chino

Chino, California, 91710, United States

ACTIVE NOT RECRUITING

Synergy Clinical Research Center - San Diego

Lemon Grove, California, 91945, United States

RECRUITING

Collaborative Neuroscience Research - Los Alamitos

Los Alamitos, California, 90720, United States

RECRUITING

NRC Research Institute - Orange

Orange, California, 92868, United States

RECRUITING

CNRI - San Diego, LLC

San Diego, California, 92123, United States

WITHDRAWN

NeuroBehavioral Hospitals of the Palm Beaches - South

Boynton Beach, Florida, 33426, United States

RECRUITING

United Research Institute

Hialeah, Florida, 33012, United States

RECRUITING

CenExel - Hollywood

Hollywood, Florida, 33024, United States

RECRUITING

Segal Trials - Miami Lakes Medical Research Early Phase, Inpatient & Outpatient Site

Miami Lakes, Florida, 33016, United States

RECRUITING

Neuroscience Research Institute at Ambrosia

West Palm Beach, Florida, 33407, United States

RECRUITING

CenExel - Decatur

Decatur, Georgia, 30030, United States

RECRUITING

Pillar Clinical Research - Chicago

Chicago, Illinois, 60641, United States

RECRUITING

CenExel - Gaithersburg

Gaithersburg, Maryland, 20877, United States

ACTIVE NOT RECRUITING

Arch Clinical Trials

St Louis, Missouri, 63125, United States

RECRUITING

Richmond Behavioral Associates

Staten Island, New York, 10314, United States

RECRUITING

New Hope Clinical Research

Charlotte, North Carolina, 28211, United States

RECRUITING

Community Clinical Research, Inc.

Austin, Texas, 78754, United States

RECRUITING

HD Research - Memorial Hermann Village

Houston, Texas, 77043, United States

RECRUITING

Pillar Clinical Research - Richardson

Richardson, Texas, 75080, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Mania

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Edwin A Gomez, MD

    CenExel Research Centers of America

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dawn F Fenton

CONTACT

(857) 323-9048dfenton@rapportrx.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a placebo-controlled trial of active drug versus placebo.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2025

First Posted

July 1, 2025

Study Start

July 25, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(22)