Trial Radar KI | ||
|---|---|---|
enums.trial_summary.trial_summary_welcome | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Bipolar I Disorder
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07046494 untersucht Behandlung im Zusammenhang mit Bipolare Störung Typ 1. Diese interventionsstudie der Phase 2 hat den Status offene rekrutierung und startete am 25. Juli 2025. Es ist geplant, 224 Teilnehmer aufzunehmen. Durchgeführt von Rapport Therapeutics Inc. wird der Abschluss für 1. Dezember 2026 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 24. November 2025 aktualisiert.
Kurzbeschreibung
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.
Ausführliche Beschreibung
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.
Offizieller Titel
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
Erkrankungen
Bipolare Störung Typ 1Weitere Studien-IDs
- RAP-219-BPM-201
NCT-Nummer
Studienbeginn (tatsächlich)
2025-07-25
Zuletzt aktualisiert
2025-11-24
Studienende (vorauss.)
2026-12
Geplante Rekrutierung
224
Studientyp
Interventionsstudie
PHASE
Phase 2
Status
Offene Rekrutierung
Stichwörter
Bipolar
Mania
Acute
In-patient
Manic State
Manic Episode
Mixed Features
Episode with Mixed Features
Mixed Mania
Bipolar Episode
Mania
Acute
In-patient
Manic State
Manic Episode
Mixed Features
Episode with Mixed Features
Mixed Mania
Bipolar Episode
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Vierfach verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellActive Arm Treatment with RAP-219 | RAP-219 RAP-219 tablets administered orally, once daily for 21 days |
Placebo-VergleichspräparatPlacebo Inert comparator matching the active treatment | PLACEBO Matching placebo tablets administered orally, once daily for 21 days |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Young Mania Rating Scale (YMRS) | The YMRS is a clinician administered scale that consists of 11 items used to assess the severity of manic symptoms (total scores range from 0 to 60). The higher the YMRS score, the more severe the subject's symptoms of mania. | Baseline to End of Treatment at Week 3 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness Mania score | The CGI-BP Severity of Illness Mania score is a clinician-rated scale used to assess the severity of manic symptoms, depression and overall illness severity in individuals with bipolar disorder. The mania score ranges from 1 (not ill) to 7 (very severely ill), with higher scores indicating greater severity of manic symptoms. | Baseline to end of Treatment at Week 3 |
Treatment Emergent Adverse Events (TEAEs) | Incidence and severity of treatment-emergent adverse events (TEAEs). | Baseline to end of Study Period 8 Weeks after date of last dose |
Heart Rate | Change in Heart Rate (BPM) | Baseline to end of Study Period 8 Weeks after date of last dose |
Respiratory Rate | Change in Respiratory Rate (breaths per minute) | Baseline to end of Study Period 8 Weeks after date of last dose |
Body Temperature | Change in body temperature | Baseline to end of Study Period 8 Weeks after date of last dose |
Blood Pressure | Change in blood pressure (Hg mm) | Baseline to end of Study Period 8 Weeks after date of last dose |
Laboratory Analytes | Change in laboratory analytes (absolute value) | Baseline to end of Study Period 8 Weeks after date of last dose |
Electrocardiogram (ECG) QTc interval | Changes in electrocardiogram (ECGs); QTc prolongation | Baseline to end of Study Period 8 Weeks after date of last dose |
Electrocardiogram (ECG) abnormal findings | Shift table of normal to abnormal ECG findings | Baseline to end of Study Period 8 Weeks after date of last dose |
Suicidality | Incidence of suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS). | Baseline to end of Study Period 8 Weeks after date of last dose |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- 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
- 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
Rapport Therapeutics Inc.Zentrale Studienkontakte
Kontakt: Dawn F Fenton, (857) 323-9048, [email protected]
22 Studienstandorte in 1 Ländern
Arkansas
Pillar Clinical Research - Little Rock, Little Rock, Arkansas, 72204, United States
Leslie Smith, MD, Kontakt
Leslie Smith, MD, Hauptprüfer
Offene Rekrutierung
Woodland International Research Group, Little Rock, Arkansas, 72211, United States
George Konis, MD, Kontakt
George Konis, MD, Hauptprüfer
Offene Rekrutierung
Woodland Research Northwest, Rogers, Arkansas, 72758, United States
Robert Billingsley, MD, Kontakt
Robert Billingsley, MD, Hauptprüfer
Offene Rekrutierung
California
Inland Psychiatric Medical Group - Chino, Chino, California, 91710, United States
Nandita Puchakayala, MD, Kontakt
Nandita Puchakayala, MD, Hauptprüfer
Offene Rekrutierung
Synergy Clinical Research Center - San Diego, Lemon Grove, California, 91945, United States
Charmaine Semeniuk, MD, Kontakt
Charmaine Semeniuk, Hauptprüfer
Offene Rekrutierung
Collaborative Neuroscience Research - Los Alamitos, Los Alamitos, California, 90720, United States
Haig Goenjian, MD, Kontakt
Haig Goenjian, Hauptprüfer
Offene Rekrutierung
NRC Research Institute - Orange, Orange, California, 92868, United States
Daniel Chueh, MD, Kontakt
Daniel Chueh, MD, Hauptprüfer
Offene Rekrutierung
CNRI - San Diego, LLC, San Diego, California, 92123, United States
Christopher Benbow, MD, Kontakt
Christopher Benbow, MD, Hauptprüfer
Offene Rekrutierung
Florida
NeuroBehavioral Hospitals of the Palm Beaches - South, Boynton Beach, Florida, 33426, United States
Mohammad Asim Nisar, MD, Kontakt
Mohammad Asim Nisar, MD, Hauptprüfer
Offene Rekrutierung
United Research Institute, Hialeah, Florida, 33012, United States
Patrick Pinchinat, MD, Kontakt
Patrick Pinchinat, Hauptprüfer
Offene Rekrutierung
CenExel - Hollywood, Hollywood, Florida, 33024, United States
Edwin Gomez, MD, Kontakt
Edwin Gomez, MD, Hauptprüfer
Offene Rekrutierung
Segal Trials - Miami Lakes Medical Research Early Phase, Inpatient & Outpatient Site, Miami Lakes, Florida, 33016, United States
Rishi Kakar, MD, Kontakt
Rishi Kakar, MD, Hauptprüfer
Offene Rekrutierung
Neuroscience Research Institute at Ambrosia, West Palm Beach, Florida, 33407, United States
Danesh Alam, MD, Kontakt
Danesh Alam, MD, Hauptprüfer
Offene Rekrutierung
Georgia
CenExel - Decatur, Decatur, Georgia, 30030, United States
Kimball Johnson, MD, Kontakt
Kimball Johnson, MD, Hauptprüfer
Offene Rekrutierung
Illinois
Pillar Clinical Research - Chicago, Chicago, Illinois, 60641, United States
Roueen Rafeyan, MD, Kontakt
Roueen Rafeyan, MD, Hauptprüfer
Offene Rekrutierung
Maryland
CenExel - Gaithersburg, Gaithersburg, Maryland, 20877, United States
Elia Acevedo-Diaz, MD, Kontakt
Elia Acevedo-Diaz, Hauptprüfer
Offene Rekrutierung
Missouri
Arch Clinical Trials, St Louis, Missouri, 63125, United States
Kulsoom Juniad, MD, Kontakt
Kulsoom Juniad, MD, Hauptprüfer
Offene Rekrutierung
New York
Richmond Behavioral Associates, Staten Island, New York, 10314, United States
Peter Weiden, Kontakt
Peter Weiden, MD, Hauptprüfer
Offene Rekrutierung
North Carolina
New Hope Clinical Research, Charlotte, North Carolina, 28211, United States
Kurian Abraham, MD, Kontakt
Kurian Abraham, Hauptprüfer
Offene Rekrutierung
Texas
Community Clinical Research, Inc., Austin, Texas, 78754, United States
Samuel Collier, MD, Kontakt
Samuel Collier, MD, Hauptprüfer
Offene Rekrutierung
HD Research - Memorial Hermann Village, Houston, Texas, 77043, United States
Dominick D'Aunno, MD, Kontakt
Dominick D'Aunno, MD, Hauptprüfer
Offene Rekrutierung
Pillar Clinical Research - Richardson, Richardson, Texas, 75080, United States
Scott Bartley, MD, Kontakt
Scott Bartley, MD, Hauptprüfer
Offene Rekrutierung