Phase 2 N=34 Treatment

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

Acute Stroke · Stroke, Ischemic

Bottom Line

View on ClinicalTrials.gov: NCT03728153 ↗

Enrolled (actual)

Serious AEs

23.5%

Results posted

May 2022

Primary outcome: Primary: Serum Sodium Concentration — 138.7 mmol/L

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Fluoxetine 20 MG Oral Tablet (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Jan 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Serum Sodium Concentration	138.7	—
PRIMARY Serum Alanine Aminotransferase (ALT)	28	—
SECONDARY Fugl-Meyer Motor Scale Score for Assessment of Motor Function After Stroke	62.7	—
SECONDARY Montgomery-Asberg Depression Rating Scale	5.6	—
SECONDARY Modified Rankin Scale	2	—
SECONDARY The Patient Health Questionnaire-9 (PHQ-9) Scale for Measuring Depression	4.6	—

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.

Eligibility Criteria

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 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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03728153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.