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

NCT ID: NCT07046494

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-25

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bipolar 1 Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a placebo-controlled trial of active drug versus placebo.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active Arm

Treatment with RAP-219

Group Type EXPERIMENTAL

RAP-219

Intervention Type DRUG

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

Placebo

Inert comparator matching the active treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Matching placebo tablets administered orally, once daily for 21 days

Interventions

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RAP-219

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

Intervention Type DRUG

Placebo

Matching placebo tablets administered orally, once daily for 21 days

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rapport Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edwin A Gomez, MD

Role: PRINCIPAL_INVESTIGATOR

CenExel Research Centers of America

Locations

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Pillar Clinical Research - Little Rock

Little Rock, Arkansas, United States

Site Status RECRUITING

Woodland International Research Group

Little Rock, Arkansas, United States

Site Status RECRUITING

Woodland Research Northwest

Rogers, Arkansas, United States

Site Status RECRUITING

Inland Psychiatric Medical Group - Chino

Chino, California, United States

Site Status RECRUITING

Synergy Clinical Research Center - San Diego

Lemon Grove, California, United States

Site Status RECRUITING

Collaborative Neuroscience Research - Los Alamitos

Los Alamitos, California, United States

Site Status RECRUITING

NRC Research Institute - Orange

Orange, California, United States

Site Status RECRUITING

CNRI - San Diego, LLC

San Diego, California, United States

Site Status RECRUITING

NeuroBehavioral Hospitals of the Palm Beaches - South

Boynton Beach, Florida, United States

Site Status RECRUITING

United Research Institute

Hialeah, Florida, United States

Site Status RECRUITING

CenExel - Hollywood

Hollywood, Florida, United States

Site Status RECRUITING

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

Miami Lakes, Florida, United States

Site Status RECRUITING

Neuroscience Research Institute at Ambrosia

West Palm Beach, Florida, United States

Site Status RECRUITING

CenExel - Decatur

Decatur, Georgia, United States

Site Status RECRUITING

Pillar Clinical Research - Chicago

Chicago, Illinois, United States

Site Status RECRUITING

CenExel - Gaithersburg

Gaithersburg, Maryland, United States

Site Status RECRUITING

Arch Clinical Trials

St Louis, Missouri, United States

Site Status RECRUITING

Richmond Behavioral Associates

Staten Island, New York, United States

Site Status RECRUITING

New Hope Clinical Research

Charlotte, North Carolina, United States

Site Status RECRUITING

Community Clinical Research, Inc.

Austin, Texas, United States

Site Status RECRUITING

HD Research - Memorial Hermann Village

Houston, Texas, United States

Site Status RECRUITING

Pillar Clinical Research - Richardson

Richardson, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Dawn F Fenton

Role: CONTACT

[email protected]
(857) 323-9048

Facility Contacts

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Nandita Puchakayala, MD

Role: primary

Charmaine Semeniuk, MD

Role: primary

Haig Goenjian, MD

Role: primary

Daniel Chueh, MD

Role: primary

Christopher Benbow, MD

Role: primary

Mohammad Asim Nisar, MD

Role: primary

Patrick Pinchinat, MD

Role: primary

Edwin Gomez, MD

Role: primary

Rishi Kakar, MD

Role: primary

Danesh Alam, MD

Role: primary

Kimball Johnson, MD

Role: primary

Roueen Rafeyan, MD

Role: primary

Elia Acevedo-Diaz, MD

Role: primary

Kulsoom Juniad, MD

Role: primary

Peter Weiden

Role: primary

Kurian Abraham, MD

Role: primary

Samuel Collier, MD

Role: primary

Dominick D'Aunno, MD

Role: primary

Scott Bartley, MD

Role: primary

Leslie Smith, MD

Role: primary

George Konis, MD

Role: primary

Robert Billingsley, MD

Role: primary

Other Identifiers

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RAP-219-BPM-201

Identifier Type: -

Identifier Source: org_study_id

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