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Recruiting NCT07046494

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

Phase II Interventional Bipolar 1 Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RAP-219, Placebo.
Who it may be relevant to
Registry conditions: Bipolar 1 Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug RAP-219
    RAP-219 tablets administered orally, once daily for 21 days
  • Other Placebo
    Matching placebo tablets administered orally, once daily for 21 days

Primary outcome measures

  • Young Mania Rating Scale (YMRS) [Time frame: Baseline to End of Treatment at Week 3]
Secondary outcome measures (10)
  • 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]

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 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. 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 22 centers
  • Pillar Clinical Research - Little Rock — Little Rock
  • Woodland International Research Group — Little Rock
  • Woodland Research Northwest — Rogers
  • Inland Psychiatric Medical Group - Chino — Chino
  • Synergy Clinical Research Center - San Diego — Lemon Grove
  • Collaborative Neuroscience Research - Los Alamitos — Los Alamitos
  • NRC Research Institute - Orange — Orange
  • CNRI - San Diego, LLC — San Diego
  • … and 14 more centers

Identifiers

NCT: NCT07046494 · RAP-219-BPM-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗