A Phase 2 interventional study of RAP-219 and Placebo in Bipolar 1 Disorder, sponsored by Rapport Therapeutics Inc.. Completed at 20 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Rapport Therapeutics Inc. · Phase 2, Interventional, and Treatment
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.
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.
166 studies on the registry are indexed under Mania; 13 are open to participants now.
This study's enrollment of 253 is above the median of 89 across 138 interventional studies indexed under Mania.
Browse Mania studies →Rapport Therapeutics Inc. is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment with RAP-219
Drug: RAP-219
Inert comparator matching the active treatment
Other: Placebo
RAP-219 tablets administered orally, once daily for 21 days
Matching placebo tablets administered orally, once daily for 21 days
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.
Time frame: Baseline to End of Treatment at Week 3
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.
Time frame: Baseline to end of Treatment at Week 3
Treatment Emergent Adverse Events (TEAEs)
Incidence and severity of treatment-emergent adverse events (TEAEs).
Time frame: Baseline to end of Study Period 8 Weeks after date of last dose
Heart Rate
Change in Heart Rate (BPM)
Time frame: Baseline to end of Study Period 8 Weeks after date of last dose
Respiratory Rate
Change in Respiratory Rate (breaths per minute)
Time frame: Baseline to end of Study Period 8 Weeks after date of last dose
Body Temperature
Change in body temperature
Time frame: Baseline to end of Study Period 8 Weeks after date of last dose
Blood Pressure
Change in blood pressure (Hg mm)
Time frame: Baseline to end of Study Period 8 Weeks after date of last dose
Laboratory Analytes
Change in laboratory analytes (absolute value)
Time frame: Baseline to end of Study Period 8 Weeks after date of last dose
Electrocardiogram (ECG) QTc interval
Changes in electrocardiogram (ECGs); QTc prolongation
Time frame: 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
Time frame: 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).
Time frame: Baseline to end of Study Period 8 Weeks after date of last dose
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2025 to primary completion in Aug 2026, 12 months.
Completion moved once since we started tracking on Sep 25, 2026: Oct 2026 → Sep 2026, on Oct 26, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: RAP-219
Rapport Therapeutics Inc.