MAMBO: Measuring Ambulation, Motor, and Behavioral Outcomes With Post-Stroke Fluoxetine in Tanzania
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Serum Sodium Concentration
研究概览
简要总结
This is a phase II, randomized study of 120 adults age 18 or above who will prescribed 20mg daily Fluoxetine for 90 days following acute, ischemic stroke.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is 18 years of age or older
- •Participant has experienced a CT-confirmed ischemic stroke w/in 21 days of enrollment
排除标准
- •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/1.73m
- •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).
研究组 & 干预措施
20mg dose
Fluoxetine 20 MG Oral Tablet
干预措施: Fluoxetine 20 MG Oral Tablet (Drug)
结局指标
主要结局
Serum Sodium Concentration
时间窗: 90 days following acute, ischemic stroke
Serum Sodium Concentration was measured in mmol/L. Hyponatremia was considered as \<125 mmol/L.
Serum Alanine Aminotransferase (ALT)
时间窗: 90 days
Hepatic impairment was measured by elevation of hepatic enzyme (serum alanine aminotransferase; ALT) of \>120 U/L
次要结局
- Fugl-Meyer Motor Scale Score for Assessment of Motor Function After Stroke(90 days following acute, ischemic stroke)
- Montgomery-Asberg Depression Rating Scale(90 days following acute, ischemic stroke)
- Modified Rankin Scale(90 days following acute, ischemic stroke)
- The Patient Health Questionnaire-9 (PHQ-9) Scale for Measuring Depression(90 days following acute ischemic stroke)
研究者
Farrah Mateen
Associate Professor
Massachusetts General Hospital