Evidence map›Paper›PMID 31731111›Full record

ArticleJournal of the neurological sciences2020

MAMBO: Measuring ambulation, motor, and behavioral outcomes with post-stroke fluoxetine in Tanzania: Protocol of a phase II clinical trial.

Andre C Vogel, Kigocha Okeng'o, Faraja Chiwanga, Seif Sharif Ismail, Deus Buma, Lindsay Pothier, Farrah J Mateen

Registry-linked trialOpen access · greenAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of the neurological sciences, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03728153 (MAMBO), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03728153 phase2completednot on this map

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

TypeinterventionalSponsorMassachusetts General HospitalRan2019 to 2021Enrolled34ConditionsAcute Stroke, Stroke, IschemicArmsFluoxetine 20 MG Oral Tablet
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Selective serotonin reuptake inhibitors (SSRIs) for stroke recovery.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Efficacy of Fluoxetine for Post-Ischemic Stroke Depression in Tanzania.Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association · 2022
    Trial
  3. Trial
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 2 countries.

Andre C VogelMassachusetts General Hospital, Department of Neurology, 165 Cambridge St. #627, Boston, MA 02114, USA. Electronic address: avogel@partners.org.
Kigocha Okeng'oMuhimbili National Hospital, Neurology Unit, Dar es Salaam, Tanzania.
Faraja ChiwangaMuhimbili National Hospital, Department of Pharmacy, Dar es Salaam, Tanzania. Electronic address: faraja.chiwanga@mnh.or.tz.
Seif Sharif IsmailMuhimbili National Hospital, Neurology Unit, Dar es Salaam, Tanzania.
Deus BumaMuhimbili National Hospital, Department of Pharmacy, Dar es Salaam, Tanzania. Electronic address: deus.buma@mnh.or.tz.
Lindsay PothierMassachusetts General Hospital, Department of Neurology, 165 Cambridge St. #627, Boston, MA 02114, USA. Electronic address: lmpothier@partners.org.
Farrah J MateenMassachusetts General Hospital, Department of Neurology, 165 Cambridge St. #627, Boston, MA 02114, USA; Harvard Medical School, 25 Shattuck St, Boston, MA 02115, USA. Electronic address: fmateen@partners.org.
Muhimbili National Hospital · TZMassachusetts General Hospital · USHarvard University · US

Funding

MAMBO: Measuring Ambulation, Motor, and Behavioral Outcomes with post-stroke Fluoxetine in TanzaniaR21TW011051 · FIC · MASSACHUSETTS GENERAL HOSPITAL · PI MATEEN, FARRAH JASMINE · 2018 to 2019
$688k
FIC NIH HHS R21 TW011051
6 · The paper itself

Abstract

backgroundSSA has a high stroke incidence and post-stroke morbidity. An inexpensive pharmacological treatment for stroke recovery would be beneficial to patients in the region. Fluoxetine, currently on the World Health Organization Essential Medicines List, holds promise as a treatment for motor recovery after ischemic stroke, but its effectiveness is controversial and untested in this context in SSA.

aimTo determine if fluoxetine 20 mg by mouth daily, given within 14 days of acute ischemic stroke, and taken for 90 days, is well-tolerated and safe with adequate adherence to justify a future randomized, controlled trial of fluoxetine in the United Republic of Tanzania.

methodsOpen-label, phase II clinical trial enrolling up to 120 patients. Participants will be recruited from the Muhimbili National Hospital in Dar es Salaam, Tanzania, and followed for 90 days. The primary outcomes are: 1) safety, including serum sodium and hepatic enzyme levels; and 2) tolerability, as measured through study case report forms. The secondary outcomes are: 1) change in motor strength, as measured through the Fugl-Meyer Motor Scale; 2) adherence, as measured with electronic pill bottles; and 3) participant depressive symptom burden measured via standard questionnaires.

conclusionsExpanding the evidence base for fluoxetine for Sub-Saharan African stroke survivors requires testing of its safety, tolerability, and adherence. Compared to prior studies in France and the United Kingdom, the patient characteristics, health infrastructure, and usual care for stroke recovery differ substantially in Tanzania. If fluoxetine reveals favorable endpoints, scale up of its use post-stroke is possible.

Indexed as

Brain IschemiaFluoxetineMotor ActivityRecovery of FunctionStrokeWalkingClinical Trials, Phase II as TopicFemaleHumansMaleRandomized Controlled Trials as TopicSelective Serotonin Reuptake InhibitorsTanzaniaTreatment OutcomeFluoxetineSelective Serotonin Reuptake InhibitorsAfricaFluoxetineIschemic strokeMotor recoveryNeuroplasticityPhase II clinical trialStroke

Identifiers

PMID31731111
PMCPMC6954330
OpenAlexW2989359490

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.