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

Launched by RAPPORT THERAPEUTICS INC. · Jun 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called RAP-219 to see if it is safe and helpful for adults with bipolar I disorder, specifically those who are experiencing manic episodes. Mania is a state of very high energy, mood, or activity that can make it hard to think clearly or control behavior. The goal of this study is to find out if RAP-219 can improve these symptoms without causing harmful side effects.

Adults who have been diagnosed with bipolar I disorder and have had at least one manic episode in the past five years may be eligible to join. People with certain other mental health conditions, like schizophrenia or severe substance use problems, or those who have very frequent mood episodes (called rapid cycling) are not eligible. If you take part, you will be carefully monitored by the study team to track how the medication works and to ensure your safety. This study is not yet recruiting participants, but it aims to help find better treatment options for people living with bipolar I disorder.

Gender

ALL

Eligibility criteria

• Inclusion 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
• 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.