RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses
Adjustment Disorder
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- Fase 2
- Rango de edad
- 18 años - 80 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 100 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms or depressive symptoms mixed with anxiety symptoms in participants with Adjustment Disorder due to cancer or other illnesses such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD) or Idiopathic Pulmonary Fibrosis (IPF) as compared to active-placebo.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- Has a ≥4 week history of AjD as defined by DSM-5-TR with either depressed mood, or mixed anxiety and depressed mood confirmed by clinical interview with evidence that the AjD was instigated by one of the following medical illnesses (e.g., diagnosis, impact, management, recurrence, prognosis): Cancer, ALS, MS, PD or IPF
- Is sufficiently ambulatory and capable of self care as necessary to complete study procedures
- Has normal cognitive function
- Is on stable use of antidepressants or psychotherapy, or is willing to delay use until the end of study
- If female is not pregnant or planning to become pregnant. If male is not planning to make a partner pregnant
- Is willing and able to comply with the conditions and requirements of the study
Exclusion Criteria:
- Has a significant risk of suicide
- Has active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder
- Has a history of current active central nervous system malignancy
- Has other medically significant conditions rendering unsuitability for the study
- Has used or will need to use prohibited medications or therapies
- Has a known sensitivity or intolerance to study intervention or potential rescue medications
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento triple
1.5 mg RE104
A single subcutaneous injection of 1.5 mg RE104 for Injection
Drug: RE104 for Injection
30 mg RE104
A single subcutaneous injection of 30 mg RE104 for Injection
Drug: RE104 for Injection
RE104 for Injection DRUG
Single, subcutaneous dose of RE104 for Injection
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score
Plazo: Day 7
Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity. The total score ranges from 0-60 with higher scores representing greater severity of depression.
Medidas secundarias
RE104 30 mg versus RE104 1.5 mg changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A)
Plazo: Day 7
The Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item scale that is used to rate the severity of symptoms of anxiety. The total score ranges from 0-56 with higher scores representing greater severity of anxiety.
RE104 30 mg versus RE104 1.5 mg incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness.
Plazo: From dosing through study completion (post-dose follow-up is for 42 days)
A treatment-emergent adverse event (TEAE) is defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a study drug.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (33)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
33 centros
UAB, Psychiatry and Behavioral NeurologyBirmingham, Alabama, United StatesReclutando
University of ArizonaTucson, Arizona, United StatesReclutando
Kadima Neuropsychiatry InstituteSan Diego, California, United StatesReclutando
Providence Medical FoundationSanta Rosa, California, United StatesTerminado antes de tiempo
University of ColoradoAurora, Colorado, United StatesReclutando
University of South Florida, Department of Psychiatry and Behavioral NeuroscienceTampa, Florida, United StatesReclutando
Emory UniversityAtlanta, Georgia, United StatesReclutando
Hawaii Pacific NeuroscienceHonolulu, Hawaii, United StatesReclutando
Rush University Medical CenterChicago, Illinois, United StatesReclutando
University of Chicago Medical CenterChicago, Illinois, United StatesReclutando
The University of Kansas Medical CenterKansas City, Kansas, United StatesReclutando
LSU Health ShreveportShreveport, Louisiana, United StatesReclutando
Sunstone Therapies, PCRockville, Maryland, United StatesReclutando
Sheppard PrattTowson, Maryland, United StatesReclutando
Dana Farber Cancer InstituteBoston, Massachusetts, United StatesReclutando
University of Massachusetts Chan Medical CenterWorcester, Massachusetts, United StatesReclutando
University of MichiganAnn Arbor, Michigan, United StatesReclutando
Henry Ford HealthNovi, Michigan, United StatesReclutando
University of Nebraska Medical CenterOmaha, Nebraska, United StatesReclutando
University of New Mexico, School of MedicineAlbuquerque, New Mexico, United StatesReclutando
Roswell Park Center InstituteBuffalo, New York, United StatesReclutando
NYU Langone HealthNew York, New York, United StatesReclutando
New York State Psychiatric InstituteNew York, New York, United StatesReclutando
University of North Carolina at Chapel HillChapel Hill, North Carolina, United StatesReclutando
Cleveland ClinicCleveland, Ohio, United StatesReclutando
The Ohio State University, Department of PsychiatryColumbus, Ohio, United StatesReclutando
University of PennsylvaniaPhiladelphia, Pennsylvania, United StatesReclutando
Alliance for Multispecialty Research ClinicalKnoxville, Tennessee, United StatesReclutando
Dell Medical School, University of Texas at AustinAustin, Texas, United StatesReclutando
Cedar Clinical Research Inc.Draper, Utah, United StatesReclutando
UVA Center for Psychiatric Clinical ResearchCharlottesville, Virginia, United StatesReclutando
Seattle Neuropsychiatric Treatment CenterSeattle, Washington, United StatesReclutando
University of Wisconsin at MadisonMadison, Wisconsin, United StatesReclutando
Equipo y fechas
- Patrocinador principal
- Reunion Neuroscience Inc
- Inicio del estudio
- 30 jul 2025 Real
- Finalización primaria
- 2027-04 Estimado
- Finalización del estudio
- 2027-05 Estimado
- Primera publicación
- 3 jun 2025 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
A Randomized, Double-Blind, Parallel-Group, Dose-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Adjustment Disorder in Patients With Cancer and Other Medical Illnesses
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026