Measuring Ambulation, Motor, and Behavioral Outcomes With Post-Stroke Fluoxetine in Tanzania

• Status: Completed
• Trial end date: 2021-01-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Muhimbili University of Health and Allied Sciences
• Treatments: Fluoxetine

Criteria

Inclusion Criteria:

1. Participant is 18 years of age or older

2. Participant has experienced a CT-confirmed ischemic stroke w/in 21 days of enrollment

Exclusion Criteria:

1. NIH Stroke Scale Score >20 points

2. Unconscious at presentation

3. Hemorrhagic conversion of ischemic infarct

4. transient ischemic symptoms <24h,

5. Current antidepressant or psychoactive drug use (e.g. SSRI, monoxidase amine inhibitor, benzodiazepine).

6. Current pregnancy.

7. History of recent head trauma.

8. Baseline motor deficits from other etiologies including prior stroke.

9. Dysphagia preventing the swallowing of a pill.

10. Hyponatremia (<125 mmol/L), hepatic impairment as defined by a serum alanine aminotransferase (ALT) of >120 U/L.

11. Renal impairment as defined by a creatinine >180 micromol/L or GFR <30mL/min/1.73m2.

12. Patients who are moribund for other reasons and unlikely to survive to 90 days will also be excluded from participation.

13. Contraindication to MRI (e.g. piercings/tattoos, electronic/metallic implants, claustrophobia)

14. 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).