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
Rapport Therapeutics Inc.
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.
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * History of any of the following diagnoses: a. schizo…
Interventions
- DrugRAP-219
RAP-219 tablets administered orally, once daily for 21 days
- OtherPlacebo
Matching placebo tablets administered orally, once daily for 21 days
Locations (22)
- Pillar Clinical Research - Little RockLittle Rock, Arkansas
- Woodland International Research GroupLittle Rock, Arkansas
- Woodland Research NorthwestRogers, Arkansas
- Inland Psychiatric Medical Group - ChinoChino, California
- Synergy Clinical Research Center - San DiegoLemon Grove, California
- Collaborative Neuroscience Research - Los AlamitosLos Alamitos, California