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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
-
-
-
Dar es Salaam, Tanzânia
- Muhimbili National Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 20mg dose
Fluoxetine 20 MG Oral Tablet
|
Once-daily dosing for 90 days
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Serum Sodium Concentration
Prazo: 90 days following acute, ischemic stroke
|
Serum Sodium Concentration was measured in mmol/L.
Hyponatremia was considered as <125 mmol/L.
|
90 days following acute, ischemic stroke
|
|
Serum Alanine Aminotransferase (ALT)
Prazo: 90 days
|
Hepatic impairment was measured by elevation of hepatic enzyme (serum alanine aminotransferase; ALT) of >120 U/L
|
90 days
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Fugl-Meyer Motor Scale Score for Assessment of Motor Function After Stroke
Prazo: 90 days following acute, ischemic stroke
|
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.
|
90 days following acute, ischemic stroke
|
|
Montgomery-Asberg Depression Rating Scale
Prazo: 90 days following acute, ischemic stroke
|
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.
|
90 days following acute, ischemic stroke
|
|
Modified Rankin Scale
Prazo: 90 days following acute, ischemic stroke
|
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.
|
90 days following acute, ischemic stroke
|
|
The Patient Health Questionnaire-9 (PHQ-9) Scale for Measuring Depression
Prazo: 90 days following acute ischemic stroke
|
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.
|
90 days following acute ischemic stroke
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Farrah J Mateen, MD, PhD, Massachusetts General Hospital
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças cardiovasculares
- Doenças Vasculares
- Distúrbios Cerebrovasculares
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Derrame
- AVC Isquêmico
- Efeitos Fisiológicos das Drogas
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Drogas Psicotrópicas
- Inibidores de Captação de Serotonina
- Inibidores de Captação de Neurotransmissores
- Moduladores de transporte de membrana
- Agentes de Serotonina
- Antidepressivos
- Inibidores da enzima citocromo P-450
- Agentes antidepressivos de segunda geração
- Inibidores do citocromo P-450 CYP2D6
- Fluoxetina
Outros números de identificação do estudo
- 2018P001693
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
produto fabricado e exportado dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .