RECRUITING

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

Conditions

Bipolar 1 Disorder Bipolar Mania Acute In-patient Manic State Manic Episode Mixed Features Mixed Episode Mixed Mania Bipolar Episode

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-07-25

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07046494

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Dawn F Fenton

CONTACT

(857) 323-9048

dfenton@rapportrx.com

Principal Investigator

Edwin A Gomez, MD

PRINCIPAL_INVESTIGATOR

CenExel Research Centers of America

Study Locations (Sites)

CenExel - Gaithersburg

Gaithersburg, Maryland, 20877

United States

Collaborators and Investigators

Sponsor: Rapport Therapeutics Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-25

Study Completion Date2026-12

Study Record Updates

Study Start Date2025-07-25

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Bipolar
Mania
Acute
In-patient
Manic State
Manic Episode
Mixed Features
Mixed Episode
Mixed Mania
Bipolar Episode

Additional Relevant MeSH Terms

Bipolar 1 Disorder