IA Trial Radar | ||
|---|---|---|
El ensayo clínico NCT07480486 (PGX-MDD) para Depression - Major Depressive Disorder está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
Un estudio coincide con los criterios de filtro
Vista de tarjeta
Pharmacogenetic-Guided Antidepressant Treatment in Depression (PGX-MDD) 570 Personalizado
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07480486 (PGX-MDD) es un estudio intervencionista para Depression - Major Depressive Disorder. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de abril de 2026 hasta completar 570 participantes. Dirigido por Mohammed V University in Rabat, se espera que finalice el 1 de mayo de 2027. Los datos se actualizaron por última vez en ClinicalTrials.gov el 25 de marzo de 2026.
Resumen
The purpose of this clinical trial is to evaluate whether using pharmacogenetic testing to guide antidepressant treatment can improve outcomes in adults with major depressive disorder in Morocco. Depression is a common mental health condition, and finding the most effective antidepressant for a patient can take time. Some individuals do not respond well to the first medication prescribed or may experience side effect...Mostrar más
Título oficial
Pharmacogenetic-Guided Antidepressant Treatment for Major Depressive Disorder: A Randomized Controlled Trial in Morocco
Condiciones médicas
Depression - Major Depressive DisorderOtros ID del estudio
- PGX-MDD
- UM5-PGX-DEP-2025
- CERB-219-25 (Otro identificador) (Biomedical Research Ethics Committee (CERB), Mohammed V University)
Número del NCT
Inicio del estudio (real)
2026-04-01
Última actualización
2026-03-25
Fecha de finalización (estimada)
2027-05-01
Inscripción (prevista)
570
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Aún no recluta
Palabras clave
Pharmacogenetics
Pharmacogenomics
Antidepressant Treatment
Precision Medicine
Major Depressive Disorder
Depression
Personalized Medicine
Pharmacogenomics
Antidepressant Treatment
Precision Medicine
Major Depressive Disorder
Depression
Personalized Medicine
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Doble ciego
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalPharmacogenetic-Guided Treatment | Pharmacogenetic-Guided Treatment Pharmacogenetic testing used to support personalized antidepressant treatment selection and dose adjustment according to the validated laboratory platform and applicable pharmacogenetic recommendations. |
Comparador activoUsual Care Participants receive standard antidepressant treatment according to routine clinical practice without access to pharmacogenetic test results. | Cuidado habitual Participants in the control group will receive standard antidepressant treatment according to routine clinical practice. Treatment decisions, including antidepressant selection and dose adjustments, will be made by the treating clinician without access to pharmacogenetic test results |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Depression Remission | Depression remission assessed using the Patient Health Questionnaire-9 (PHQ-9), a self-reported instrument with scores ranging from 0 to 27, where higher scores indicate greater depression severity and worse outcomes.
Remission is defined as a PHQ-9 score ≤5 at 12 weeks after randomization. | 12 weeks post-randomization |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Depression Severity | Severity of depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9), a self-reported scale ranging from 0 to 27, where higher scores indicate greater depression severity and worse outcomes.
The outcome will be analyzed as the change in PHQ-9 score from baseline to 12 weeks post-randomization. | 12 weeks post-randomization |
Depression Response | Treatment response defined as a ≥50% reduction in PHQ-9 score from baseline to 12 weeks post-randomization, using the Patient Health Questionnaire-9 (PHQ-9) (range: 0-27; higher scores indicate worse outcomes). | 12 weeks post-randomization |
Medication Tolerability | Tolerability of antidepressant treatment assessed using the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) scale. The FIBSER evaluates three domains (frequency, intensity, and burden of side effects), each scored from 0 to 6, yielding a total score ranging from 0 to 18, where higher total scores indicate greater side effect burden and worse tolerability outcomes. | 12 weeks post-randomization |
Global Clinical Improvement | Global clinical improvement assessed using the Clinical Global Impression-Improvement (CGI-I) scale, a clinician-rated instrument scored from 1 to 7, where 1 indicates very much improved and 7 indicates very much worse. Lower scores reflect better clinical outcomes. | 12 weeks post-randomization |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- Diagnosis of a depressive disorder (major depressive disorder, depressive episode, or persistent depressive disorder) confirmed by a healthcare professional according to DSM-5 or ICD-10 criteria.
- Aged 18 years or older at the time of enrollment.
- Clinical indication for initiation or modification of antidepressant pharmacotherapy.
- Ability to understand study procedures and provide written informed consent.
- Inability to provide informed consent.
- Current acute psychotic disorder, manic episode, or uncontrolled bipolar disorder.
- Current pregnancy or breastfeeding.
- Use of medications with clinically significant interactions with antidepressants.
- Any severe medical condition that, in the opinion of the investigator, would compromise participant safety or study integrity.
Mohammed V University in RabatIbn Sina University Hospital, Rabat, MoroccoParte responsable del estudio
Atarki Meriem, Investigador principal, PhD Candidate, Mohammed V University in Rabat
Contactos centrales del estudio
Contacto: Meriem Atarki, PhD, +212687595174, [email protected]
1 Centros del estudio en 1 países
Rabat-Salé-Kénitra
Ar-Razi Psychiatric Hospital, Ibn Sina University Hospital, Rabat, Rabat-Salé-Kénitra, 40000, Morocco
Meriem Atarki, PhD Candidate, Contacto, +212687595174, [email protected]
Contacto, [email protected]
Meriem Atarki, PhD Candidate, Investigador principal
Siham Belbachir, MD, Subinvestigador
Elmostafa El Fahime, PhD, Subinvestigador
Abderrazzak Ouanass, MD, Subinvestigador