Un estudio para evaluar la seguridad, la tolerabilidad y la eficacia de XEN1101 en el trastorno depresivo mayor (X-NOVA)
Estudio de prueba de concepto, aleatorizado, doble ciego, controlado con placebo y multicéntrico para evaluar la seguridad, la tolerabilidad y la eficacia de XEN1101 en el trastorno depresivo mayor
This is a multicenter, Phase 2, double-blind, randomized, parallel-arm, placebo-controlled clinical trial to evaluate the efficacy, safety, and tolerability of XEN1101 in subjects with Major Depressive Disorder.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study is divided into 3 stages: Screening - up to 4 weeks duration; Treatment - 6 weeks duration; Follow-up - 4 weeks duration. The total study duration per subject is estimated to be approximately 14 weeks.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Anaheim, California, Estados Unidos, 92805
- Advanced Research Center
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Lafayette, California, Estados Unidos, 94549
- Sunwise Clinical Research, LLC
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Pico Rivera, California, Estados Unidos, 90660
- California Neuropsychopharmacology Clinical Research Institute
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Riverside, California, Estados Unidos, 92503
- Artemis Institute for Clinical Research
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San Diego, California, Estados Unidos, 92103
- Artemis Institute for Clinical Research
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Florida
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Miami, Florida, Estados Unidos, 33014
- Meridian International Research
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Miami, Florida, Estados Unidos, 33125
- Global Medical Institutes (GMI)
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Miami, Florida, Estados Unidos, 33133
- CCM Clinical Reseach Group, LLC
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Georgia
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Decatur, Georgia, Estados Unidos, 30030
- i-Research, Atlanta
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Marietta, Georgia, Estados Unidos, 30060
- Psych Atlanta, PC
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Savannah, Georgia, Estados Unidos, 31405
- iResearch
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Illinois
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Elgin, Illinois, Estados Unidos, 60123
- Revive Research Institute, Inc.
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89102
- Altea Research
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New Jersey
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Marlton, New Jersey, Estados Unidos, 08009
- Hassman Research Institute
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Toms River, New Jersey, Estados Unidos, 08755
- Bio Behavioral Health
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New York
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Cedarhurst, New York, Estados Unidos, 11516
- Neurobehavioral Research, Inc. (NBR)
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New York, New York, Estados Unidos, 10036
- Manhattan Behavioral Medicine, PLLC
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North Carolina
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Raleigh, North Carolina, Estados Unidos, 27609
- Richard M Weisler and Association
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Texas
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Dallas, Texas, Estados Unidos, 75231
- FutureSearch Trials of Dallas, LP
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Plano, Texas, Estados Unidos, 75093
- AIM Trials
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Key Inclusion Criteria:
- Be properly informed of the nature and risks of the study and given written informed consent.
- Male or female, aged 18 through 65 years (inclusive) with a body mass index (BMI) ≤35 kg/m².
- Subject must meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current MDD and currently in a moderate to severe major depressive episode (MDE), confirmed using the Mini International Neuropsychiatric Interview (MINI).
- Current MDE duration ≥2 months and <24 months at the time of screening.
- Current illness severity that is at least moderate, defined as a score of ≥20 on the HAM-D17 at screening and on Day 1.
- Score ≥20 on the SHAPS at screening and on Day1.
- Must be willing to comply with the study protocol for the full term of the study.
Key Exclusion Criteria:
- A primary psychiatric diagnosis other than MDD as defined by DSM-5 (comorbid anxiety disorders [including agoraphobia, generalized anxiety disorder, social anxiety disorder, post-traumatic stress disorder (PTSD), and panic disorder] are allowed).
- Concomitant use of antidepressants and/or other disallowed pharmacotherapy (including benzodiazepines).
- History of schizophrenia or other psychotic disorder, MDD with psychotic features, bipolar I or II disorder, or MDD with mixed features.
- History of non-response to >1 antidepressant drug due to lack of efficacy in the current MDE.
- Failing >3 antidepressant drug trials, for any reason, in the current MDE.
- History of non-response to electroconvulsive therapy (ECT) in the past 10 years.
- Active suicidal plan/intent in the past 6 months, or more than 1 lifetime suicide attempt.
- Females who are pregnant, breastfeeding, or planning to become pregnant during the first administration of study drug until 3 months after the last dose of study drug.
- Meets criteria for a substance use disorder within the past 12 months, with the exception of tobacco use, and/or has a positive urine toxicology screen for drugs of abuse.
- Any medical condition or personal circumstance that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study or prevents adherence to the protocol.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: XEN1101 10 mg
During the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 10 mg, orally with food, per day |
XEN1101 oral capsule |
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Experimental: XEN1101 20 mg
During the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 20 mg, orally with food, per day |
XEN1101 oral capsule |
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Comparador de placebos: placebo
During the double blind treatment period (42 days), subjects will take 1 capsule of placebo, orally with food, per day |
Placebo capsule |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score.
Periodo de tiempo: From baseline to end of treatment (Week 6).
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Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated, 10-item scale used to assess the severity of depressive symptoms. Each item is scored from 0 (normal/absent) to 6 (severe), yielding a total score ranging from 0 to 60, with higher scores indicating greater depression severity. MADRS total score change from baseline at week 6. |
From baseline to end of treatment (Week 6).
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Snaith-Hamilton Pleasure Scale (SHAPS) Score.
Periodo de tiempo: From baseline to end of treatment (Week 6).
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Snaith-Hamilton Pleasure Scale (SHAPS) is a validated 14-item self-report questionnaire commonly used to assess anhedonia (reduced ability to experience pleasure). Each of the 14 items is rated from 1 (strongly agree) to 4 (strongly disagree). Total scores range from 14 to 56, with higher scores indicating greater levels of anhedonia. SHAPS total score change from baseline at week 6 |
From baseline to end of treatment (Week 6).
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Change in Beck Anxiety Inventory (BAI) Score.
Periodo de tiempo: From baseline to end of treatment (Week 6).
|
Beck Anxiety Inventory (BAI) is a 21-item self-report questionnaire used to assess the severity of anxiety symptoms. Each item is scored on a scale from 0 (not at all) to 3 (severely), yielding a total score ranging from 0 to 63, with higher scores indicating greater anxiety severity. BAI total score change from baseline at week 6 |
From baseline to end of treatment (Week 6).
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Study Director, Xenon Pharmaceuticals Inc.
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- XPF-008-204
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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