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

Rapport Therapeutics Inc.

Status and phase: Not yet enrolling; Phase 2

Conditions: Bipolar 1 Disorder

Treatments: Drug: RAP-219; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07046494

RAP-219-BPM-201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 224 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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224 participants in 2 patient groups, including a placebo group

Active Arm

Experimental group

Description:

Treatment with RAP-219

Treatment:

Drug: RAP-219

Placebo

Placebo Comparator group

Description:

Inert comparator matching the active treatment

Treatment:

Other: Placebo