Measuring Ambulation, Motor, and Behavioral Outcomes With Post-Stroke Fluoxetine in Tanzania (MAMBO)
MAMBO: Measuring Ambulation, Motor, and Behavioral Outcomes With Post-Stroke Fluoxetine in Tanzania
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a prospective, phase II study of fluoxetine for motor recovery post-stroke in adults with new-onset ischemic stroke in urban Tanzania. Participants will be enrolled at the Muhimbili National Hospital (MNH) in Dar Es Salaam after confirmation of exclusion and inclusion criteria, including a head CT. Participants will be enrolled within 21 days of acute, ischemic stroke. The study will utilize a novel method for monitoring patient medication adherence: electronic pill bottles that can record medication use events. The primary goals of this study are to assess the safety and tolerability of fluoxetine post-stroke to evaluate the feasibility of conducting a larger, phase III study in the future.
Vital status will be monitored throughout the study's enrollment period. At enrollment, participants will have cognitive tests administered, receive lumbar puncture, and receive an MRI brain. After discharge from the hospital, participants will be seen at 30-, 60-, and 90-days post-enrollment for an in-person study visit. At each time point, investigators will draw 10-15 mL of blood; download medication adherence data from participants' electronic pill bottles; and inquire about adverse events and evaluate patient disability through the modified Rankin Scale. If participants stop taking their daily pill, stroke specific reasons for non-adherence will be inquired including dysphagia, self-administration, and other concerns.
Primary assessments will be for safety and tolerability, as well as measurement of the Fugl-Meyer Motor Scale. Medication use data will also be collected through the electronic pill bottle, which will be returned to study investigators. As secondary assessments, the PHQ-9, and the Asberg Depressive Symptom Questionnaire will be administered. All 90-day assessments will be administered by senior site investigators, who will take a final 10-15mL blood draw to test for serum sodium and liver enzymes, possible adverse events related to long-term fluoxetine use, conduct a second MRI brain, evaluate participant mRS, and inquire about tolerability issues. Completion of the 90-day visit and associated assessments is considered the study endpoint.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Dar es Salaam, Tanzania
- Muhimbili National Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Participant is 18 years of age or older
- Participant has experienced a CT-confirmed ischemic stroke w/in 21 days of enrollment
Exclusion Criteria:
- NIH Stroke Scale Score >20 points
- Unconscious at presentation
- Hemorrhagic conversion of ischemic infarct
- transient ischemic symptoms <24h,
- Current antidepressant or psychoactive drug use (e.g. SSRI, monoxidase amine inhibitor, benzodiazepine).
- Current pregnancy.
- History of recent head trauma.
- Baseline motor deficits from other etiologies including prior stroke.
- Dysphagia preventing the swallowing of a pill.
- Hyponatremia (<125 mmol/L), hepatic impairment as defined by a serum alanine aminotransferase (ALT) of >120 U/L.
- Renal impairment as defined by a creatinine >180 micromol/L or GFR <30mL/min/1.73m2.
- Patients who are moribund for other reasons and unlikely to survive to 90 days will also be excluded from participation.
- Contraindication to MRI (e.g. piercings/tattoos, electronic/metallic implants, claustrophobia)
- Contraindication to lumbar puncture (e.g. infection at site of needle insertion, evidence of elevated ICP, coagulopathy/thrombocytopenia or use of therapeutic anticoagulation, or a history of LP complications).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 20mg dose
Fluoxetine 20 MG Oral Tablet
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Once-daily dosing for 90 days
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Serum Sodium Concentration
Periodo de tiempo: 90 days following acute, ischemic stroke
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Serum Sodium Concentration was measured in mmol/L.
Hyponatremia was considered as <125 mmol/L.
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90 days following acute, ischemic stroke
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Serum Alanine Aminotransferase (ALT)
Periodo de tiempo: 90 days
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Hepatic impairment was measured by elevation of hepatic enzyme (serum alanine aminotransferase; ALT) of >120 U/L
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90 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Fugl-Meyer Motor Scale Score for Assessment of Motor Function After Stroke
Periodo de tiempo: 90 days following acute, ischemic stroke
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The Fugl Meyer motor scale is used to assess post-stroke motor recovery in stroke patients.
It is scored on a scale from 0 to 100, with lower scores indicating greater disability.
It evaluates both lower and upper extremities for motor performance: 66 points are allocated to the upper extremities, 34 to the lower extremities.
The two extremities are summed to achieve the total score.
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90 days following acute, ischemic stroke
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Montgomery-Asberg Depression Rating Scale
Periodo de tiempo: 90 days following acute, ischemic stroke
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10-item questionnaire used to evaluate the severity of a patient's depressive symptoms.
Each item is scored on a scale from 0 to 6, the scores are summed, and the total score (0 to 60 points) is reported.
The greater the score, the more severe the degree of depression.
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90 days following acute, ischemic stroke
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Modified Rankin Scale
Periodo de tiempo: 90 days following acute, ischemic stroke
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Validated instrument for measuring the degree of disability in stroke patients.
The modified Rankin Scale is based on a physicians subjective evaluation.
The scale ranges from 0, indicating perfect health, to 6, indicating that the patient is dead.
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90 days following acute, ischemic stroke
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The Patient Health Questionnaire-9 (PHQ-9) Scale for Measuring Depression
Periodo de tiempo: 90 days following acute ischemic stroke
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The PHQ-9 is a validated 9-point questionnaire for measuring depression symptom severity.
Each question is scored from 0-3.
Answers are summed and the total score (0 to 27) is reported.
The greater the score, the greater the severity of depression.
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90 days following acute ischemic stroke
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Farrah J Mateen, MD, PhD, Massachusetts General Hospital
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
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Carrera
- Accidente cerebrovascular isquémico
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Drogas psicotropicas
- Inhibidores de la captación de serotonina
- Inhibidores de la captación de neurotransmisores
- Moduladores de transporte de membrana
- Agentes de serotonina
- Agentes antidepresivos
- Inhibidores de enzimas del citocromo P-450
- Agentes antidepresivos, segunda generación
- Inhibidores del citocromo P-450 CYP2D6
- Fluoxetina
Otros números de identificación del estudio
- 2018P001693
Plan de datos de participantes individuales (IPD)
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Descripción del plan 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.
producto fabricado y exportado desde los EE. UU.
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