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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Young Mania Rating Scale (YMRS) [Срок оценки: Baseline to End of Treatment at Week 3]

Вторичные конечные точки (10)

• Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness Mania score [Срок оценки: Baseline to end of Treatment at Week 3]
• Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Baseline to end of Study Period 8 Weeks after date of last dose]
• Heart Rate [Срок оценки: Baseline to end of Study Period 8 Weeks after date of last dose]
• Respiratory Rate [Срок оценки: Baseline to end of Study Period 8 Weeks after date of last dose]
• Body Temperature [Срок оценки: Baseline to end of Study Period 8 Weeks after date of last dose]
• Blood Pressure [Срок оценки: Baseline to end of Study Period 8 Weeks after date of last dose]
• Laboratory Analytes [Срок оценки: Baseline to end of Study Period 8 Weeks after date of last dose]
• Electrocardiogram (ECG) QTc interval [Срок оценки: Baseline to end of Study Period 8 Weeks after date of last dose]
• Electrocardiogram (ECG) abnormal findings [Срок оценки: Baseline to end of Study Period 8 Weeks after date of last dose]
• Suicidality [Срок оценки: Baseline to end of Study Period 8 Weeks after date of last dose]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 22 центра

• 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
• … и ещё 14 центров

Идентификаторы

NCT: NCT07046494 · RAP-219-BPM-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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