Bipolar 1 DisorderPhase 2NCT07046494
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Bipolar I Disorder
A Phase 2 study testing RAP-219 in people with Bipolar 1 Disorder, run by Rapport Therapeutics Inc. at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar 1 Disorder
- What is being tested?
- RAP-219
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 253 participants
- Where
- 20 sitesUnited States
- Study dates
- 25 Jul 2025to 24 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Community Clinical Research, Inc.
Austin, Texas, 78754
NeuroBehavioral Hospitals of the Palm Beaches - South
Boynton Beach, Florida, 33426
New Hope Clinical Research
Charlotte, North Carolina, 28211
Pillar Clinical Research - Chicago
Chicago, Illinois, 60641
Inland Psychiatric Medical Group - Chino
Chino, California, 91710
CenExel - Decatur
Decatur, Georgia, 30030
CenExel - Gaithersburg
Gaithersburg, Maryland, 20877
United Research Institute
Hialeah, Florida, 33012
CenExel - Hollywood
Hollywood, Florida, 33024
HD Research - Memorial Hermann Village
Houston, Texas, 77043
Synergy Clinical Research Center - San Diego
Lemon Grove, California, 91945
Pillar Clinical Research - Little Rock
Little Rock, Arkansas, 72204
Collaborative Neuroscience Research - Los Alamitos
Los Alamitos, California, 90720
Segal Trials - Miami Lakes Medical Research Early Phase, Inpatient & Outpatient Site
Miami Lakes, Florida, 33016
NRC Research Institute - Orange
Orange, California, 92868
Pillar Clinical Research - Richardson
Richardson, Texas, 75080
Woodland Research Northwest
Rogers, Arkansas, 72758
Arch Clinical Trials
St Louis, Missouri, 63125
Richmond Behavioral Associates
Staten Island, New York, 10314
Neuroscience Research Institute at Ambrosia
West Palm Beach, Florida, 33407
About this study
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
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.
Read the detailed description
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
- Bipolar 1 Disorder
- Being tested
- RAP-219, Placebo
- Keywords
- Bipolar, Mania, Acute, In-patient, Manic State, Manic Episode, Mixed Features, Episode with Mixed Features, Mixed Mania, Bipolar Episode
- Medical subject headings
- Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAP-219Drug
RAP-219 tablets administered orally, once daily for 21 days
PlaceboOther
Matching placebo tablets administered orally, once daily for 21 days
| Study group | Role | What they receive |
|---|---|---|
| Active Arm | Experimental | Treatment with RAP-219 Receives: Drug: RAP-219 |
| Placebo | Placebo comparator | Inert comparator matching the active treatment Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to End of Treatment at Week 3
Secondary outcomes (10)
Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness Mania score
The CGI-BP Severity of Illness Mania score is a clinician-rated scale used to assess the severity of manic symptoms, depression and overall illness severity in individuals with bipolar disorder. The mania score ranges from 1 (not ill) to 7 (very severely ill), with higher scores indicating greater severity of manic symptoms.
Measured: Baseline to end of Treatment at Week 3
Treatment Emergent Adverse Events (TEAEs)
Incidence and severity of treatment-emergent adverse events (TEAEs).
Measured: Baseline to end of Study Period 8 Weeks after date of last dose
Heart Rate
Change in Heart Rate (BPM)
Measured: Baseline to end of Study Period 8 Weeks after date of last dose
Respiratory Rate
Change in Respiratory Rate (breaths per minute)
Measured: Baseline to end of Study Period 8 Weeks after date of last dose
Body Temperature
Change in body temperature
Measured: Baseline to end of Study Period 8 Weeks after date of last dose
Blood Pressure
Change in blood pressure (Hg mm)
Measured: Baseline to end of Study Period 8 Weeks after date of last dose
Laboratory Analytes
Change in laboratory analytes (absolute value)
Measured: Baseline to end of Study Period 8 Weeks after date of last dose
Electrocardiogram (ECG) QTc interval
Changes in electrocardiogram (ECGs); QTc prolongation
Measured: Baseline to end of Study Period 8 Weeks after date of last dose
Electrocardiogram (ECG) abnormal findings
Shift table of normal to abnormal ECG findings
Measured: Baseline to end of Study Period 8 Weeks after date of last dose
Suicidality
Incidence of suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS).
Measured: Baseline to end of Study Period 8 Weeks after date of last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start25 Jul 2025
- Primary completion5 Aug 2026
- Study completion24 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar 1 DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a placebo-controlled trial of active drug versus placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rapport Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edwin A Gomez, MD, Principal investigator, CenExel Research Centers of America
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046494
- Sponsor's protocol ID
- RAP-219-BPM-201
- Status last verified
- Oct 2026
- First submitted
- 30 May 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07046494
- Acronym / sponsor ID
- RAP-219-BPM-201
- Conditions
- Bipolar 1 Disorder
- Keywords
- Bipolar, Mania, Acute, In-patient, Manic State, Manic Episode, Mixed Features, Episode with Mixed Features
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Rapport Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 5 Aug 2026 (actual)
- Study completion
- 24 Sep 2026 (actual)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a placebo-controlled trial of active drug versus placebo.
| Arm | Type | Receives |
|---|---|---|
| Active Arm | Experimental | Drug: RAP-219Treatment with RAP-219 |
| Placebo | Placebo comparator | Other: PlaceboInert comparator matching the active treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAP-219RAP-219 tablets administered orally, once daily for 21 days | Drug | Active Arm |
| PlaceboMatching placebo tablets administered orally, once daily for 21 days | Other | Placebo |
Primary outcome
Young Mania Rating Scale (YMRS)
Time frame: Baseline to End of Treatment at Week 3
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.
10 secondary outcomes
Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness Mania score
Time frame: Baseline to end of Treatment at Week 3
Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline to end of Study Period 8 Weeks after date of last dose
Heart Rate
Time frame: Baseline to end of Study Period 8 Weeks after date of last dose
Respiratory Rate
Time frame: Baseline to end of Study Period 8 Weeks after date of last dose
Body Temperature
Time frame: Baseline to end of Study Period 8 Weeks after date of last dose
Blood Pressure
Time frame: Baseline to end of Study Period 8 Weeks after date of last dose
Laboratory Analytes
Time frame: Baseline to end of Study Period 8 Weeks after date of last dose
Electrocardiogram (ECG) QTc interval
Time frame: Baseline to end of Study Period 8 Weeks after date of last dose
Electrocardiogram (ECG) abnormal findings
Time frame: Baseline to end of Study Period 8 Weeks after date of last dose
Suicidality
Time frame: Baseline to end of Study Period 8 Weeks after date of last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edwin A Gomez, MD principal investigator
CenExel Research Centers of America
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RAP-219 in people with Bipolar 1 Disorder, run by Rapport Therapeutics Inc. at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Young Mania Rating Scale (YMRS) (time frame: Baseline to End of Treatment at Week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.