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

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ClinicalTrials.gov Identifier: NCT03728153
Recruitment Status : Completed
First Posted : November 1, 2018
Last Update Posted : February 23, 2021
Sponsor:
Collaborator:
Muhimbili University of Health and Allied Sciences
Information provided by (Responsible Party):
Farrah Mateen, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Stroke Stroke, Ischemic Drug: Fluoxetine 20 MG Oral Tablet Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Phase II study of one dose
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MAMBO: Measuring Ambulation, Motor, and Behavioral Outcomes With Post-Stroke Fluoxetine in Tanzania
Actual Study Start Date : November 26, 2019
Actual Primary Completion Date : January 6, 2021
Actual Study Completion Date : January 6, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

Arm Intervention/treatment
Experimental: 20mg dose
Fluoxetine 20 MG Oral Tablet
Drug: Fluoxetine 20 MG Oral Tablet
Once-daily dosing for 90 days
Other Name: Prozac 20 MG Oral Tablet




Primary Outcome Measures :
  1. Serum sodium or elevation of hepatic enzyme (ALT) [ Time Frame: 30 days following acute, ischemic stroke ]
    hyponatremia (<125 mmol/L); hepatic impairment as defined by a serum alanine aminotransferase (ALT) of >120 U/L,

  2. Serum sodium or elevation of hepatic enzyme (ALT) [ Time Frame: 60 days following acute, ischemic stroke ]
    hyponatremia (<125 mmol/L); hepatic impairment as defined by a serum alanine aminotransferase (ALT) of >120 U/L,

  3. Serum sodium or elevation of hepatic enzyme (ALT) [ Time Frame: 90 days following acute, ischemic stroke ]
    hyponatremia (<125 mmol/L); hepatic impairment as defined by a serum alanine aminotransferase (ALT) of >120 U/L,


Secondary Outcome Measures :
  1. Fugl-Meyer Motor Scale Score for assessment of motor function after stroke [ Time Frame: 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.

  2. Montgomery-Asberg Depression Rating Scale [ Time Frame: 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.

  3. modified Rankin Scale [ Time Frame: <21 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.

  4. modified Rankin Scale [ Time Frame: 30 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.

  5. modified Rankin Scale [ Time Frame: 60 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.

  6. modified Rankin Scale [ Time Frame: 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.

  7. The PHQ-9 scale for measuring depression [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728153


Locations
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Tanzania
Muhimbili National Hospital
Dar es Salaam, Tanzania
Sponsors and Collaborators
Massachusetts General Hospital
Muhimbili University of Health and Allied Sciences
Investigators
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Principal Investigator: Farrah J Mateen, MD, PhD Massachusetts General Hospital
Publications:

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Responsible Party: Farrah Mateen, Associate Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03728153    
Other Study ID Numbers: 2018P001693
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Contingent upon the requirements of the Tanzanian National Medical Institute for Research

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Farrah Mateen, Massachusetts General Hospital:
Motor recovery
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors