Measuring Ambulation, Motor, and Behavioral Outcomes With Post-Stroke Fluoxetine in Tanzania
Condition: Acute Stroke; Stroke, Ischemic
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Fluoxetine 20 MG Oral Tablet
Intervention type(s): Drug
Intervention description(s): Once-daily dosing for 90 days
Other intervention name(s): Prozac 20 MG Oral Tablet
Intervention MeSH terms: Fluoxetine
Intervention model: Single Group Assignment
Intervention model description: Phase II study of one dose
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Motor recovery