Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New pill RAP-219 aims to tame mania in bipolar disorder

NCT ID NCT07046494

Symptom relief Sponsor: Rapport Therapeutics Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This study tests an experimental drug called RAP-219 for people with bipolar I disorder who are currently experiencing a manic episode. About 250 participants will receive either RAP-219 or a placebo daily for 21 days. Researchers will measure changes in manic symptoms using a standard rating scale to see if the drug is safe and effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RAP-219 (oral tablet)
What this could lead to
If it works, this could provide a new short-term treatment option to quickly reduce manic symptoms in people with bipolar I disorder.
What could go wrong
This is an early Phase 2 trial with only 250 participants, so results may not apply to everyone. The drug may prove no better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

253 people

The number who actually took part.

Started

Jul 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Bipolar 1 disorder are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

bipolar I disorder Mania

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bipolar 1 disorder

Contacts and locations

Locations

  • Arch Clinical Trials

    St Louis, Missouri, 63125, United States

  • CenExel - Decatur

    Decatur, Georgia, 30030, United States

  • CenExel - Gaithersburg

    Gaithersburg, Maryland, 20877, United States

  • CenExel - Hollywood

    Hollywood, Florida, 33024, United States

  • Collaborative Neuroscience Research - Los Alamitos

    Los Alamitos, California, 90720, United States

  • Community Clinical Research, Inc.

    Austin, Texas, 78754, United States

  • HD Research - Memorial Hermann Village

    Houston, Texas, 77043, United States

  • Inland Psychiatric Medical Group - Chino

    Chino, California, 91710, United States

  • NRC Research Institute - Orange

    Orange, California, 92868, United States

  • NeuroBehavioral Hospitals of the Palm Beaches - South

    Boynton Beach, Florida, 33426, United States

  • Neuroscience Research Institute at Ambrosia

    West Palm Beach, Florida, 33407, United States

  • New Hope Clinical Research

    Charlotte, North Carolina, 28211, United States

  • Pillar Clinical Research - Chicago

    Chicago, Illinois, 60641, United States

  • Pillar Clinical Research - Little Rock

    Little Rock, Arkansas, 72204, United States

  • Pillar Clinical Research - Richardson

    Richardson, Texas, 75080, United States

  • Richmond Behavioral Associates

    Staten Island, New York, 10314, United States

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

    Miami Lakes, Florida, 33016, United States

  • Synergy Clinical Research Center - San Diego

    Lemon Grove, California, 91945, United States

  • United Research Institute

    Hialeah, Florida, 33012, United States

  • Woodland Research Northwest

    Rogers, Arkansas, 72758, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.