Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07046494 · ClinicalTrials.gov registry record · Phase 2
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Bipolar I Disorder
A Phase 2 study of Bipolar 1 Disorder, sponsored by Rapport Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 224
- Enrollment target
- 20
- Study locations
NCT07046494: Recruiting Phase 2 study of Bipolar 1 Disorder, sponsored by Rapport Therapeutics.
NCT07046494 is a Phase 2 study of Bipolar 1 Disorder that is actively recruiting participants, run by Rapport Therapeutics. The registered enrollment target is 224 participants, below the 445-participant average among 3 other Bipolar 1 Disorder trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07046494, a Phase 2 study of Bipolar 1 Disorder, is actively recruiting participants, sponsored by Rapport Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 224 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG RAP-219
Study Locations (20)
California
- Inland Psychiatric Medical Group - Chino - Chino
- Synergy Clinical Research Center - San Diego - Lemon Grove
- Collaborative Neuroscience Research - Los Alamitos - Los Alamitos
- NRC Research Institute - Orange - Orange
- CNRI - San Diego, LLC - San Diego
Florida
- NeuroBehavioral Hospitals of the Palm Beaches - South - Boynton Beach
- United Research Institute - Hialeah
- CenExel - Hollywood - Hollywood
- Segal Trials - Miami Lakes Medical Research Early Phase, Inpatient & Outpatient Site - Miami Lakes
- Neuroscience Research Institute at Ambrosia - West Palm Beach
Arkansas
- Pillar Clinical Research - Little Rock - Little Rock
- Woodland International Research Group - Little Rock
- Woodland Research Northwest - Rogers
Georgia
- CenExel - Decatur - Decatur
Illinois
- Pillar Clinical Research - Chicago - Chicago
Maryland
- CenExel - Gaithersburg - Gaithersburg
Missouri
- Arch Clinical Trials - St Louis
New York
- Richmond Behavioral Associates - Staten Island
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2025-07-25 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What NCT07046494 shows while recruiting
NCT07046494 is an interventional study that assigns participants to a tested intervention. The registered 224 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 3 other Bipolar 1 Disorder trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Bipolar 1 Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07046494 names 20 study sites across 10 states, led by California, Florida, Arkansas.
Frequently Asked Questions
What is clinical trial NCT07046494 about?
NCT07046494 is a clinical study titled "Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Bipolar I Disorder". 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.
What is the current status of trial NCT07046494?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 224 participants. The study started on 2025-07-25. Estimated completion is 2026-12.
What conditions does trial NCT07046494 study?
This clinical trial studies the following conditions: Bipolar 1 Disorder.
What interventions are being tested in trial NCT07046494?
The interventions under investigation include: Placebo (OTHER), RAP-219 (DRUG).
Who is sponsoring clinical trial NCT07046494?
This trial is sponsored by Rapport Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07046494 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar 1 Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02706561 · 224 participants · NA
Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery
- NCT04140344 · 224 participants · NA
The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
- NCT04915183 · 224 participants · Phase 2
Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer
- NCT05519878 · 224 participants · NA
Light Therapy and Occupational Therapy Fatigue Management-Based Intervention for Patients With Genitourinary Cancers
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI