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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201412000967245 |
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Date of registration:
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10/12/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pharmacological enhancement of motor function recovery in patients with ischaemic stroke: a trial of fluoxetine.
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Scientific title:
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Pharmacological enhancement of motor function recovery in patients with ischaemic stroke: a trial of fluoxetine. |
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Date of first enrolment:
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01/01/2015 |
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Target sample size:
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60 |
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Recruitment status: |
Pending |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=967 |
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Study type:
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Interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,Randomised,Permuted block randomization, using blocks of 6, non-varied.,Sealed opaque envelopes
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Phase:
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Phase-0
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Countries of recruitment
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Nigeria
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Contacts
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Name:
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Bertha
Ekeh |
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Address:
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Abak road Uyo
530001
Uyo
Nigeria |
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Telephone:
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+2348034018391 |
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Email:
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berthacekeh@yahoo.com |
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Affiliation:
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consultant neurologist |
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Name:
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Dike
franklin |
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Address:
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Abak road Uyo
530001
uyo
Nigeria |
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Telephone:
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+2347033038651 |
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Email:
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frankincense4m@yahoo.com |
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Affiliation:
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senior registrar |
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Key inclusion & exclusion criteria
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Inclusion criteria: (1) 18- 85yrs of age
(2) Ischaemic stroke, unilateral, supra-tentorialconfirmed by neuroimaging.
(3) Presentation within first 14 days of ictus
(4) NIHSS score (5) Hemiparesis or hemiplegia, FMMS (6) Informed consent.
Exclusion criteria: (1) Glasgow coma score < 8,
(2) NIHSS score >16
(3) Cardiovascular/metabolic /respiratory instability-: hypertensive emergency or hypotension/ acidosis or alkalosis/ RR >24cycles per min.
(4) Previous central /peripheral nerve injury
(5) Concurrent medications interacting with SSRI¿s
(6) Haemorrhagic stroke on CT
(7) Substantial premorbid disability
(8) Depression (Montgomery-Åsberg Depression Rating Scale MADRS score >19), taking anti-depressant drugs, MAOI, neuroleptic drugs or benzodiazepines during the month before inclusion.
(9) Pregnancy.
(10) No consent.
Age minimum:
18 Year(s)
Age maximum:
85 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Stroke
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Stroke
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Intervention(s)
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standard treatment
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fluoxetine plus standard treatment
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Primary Outcome(s)
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Changes in Fugl Meyr Motor score
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Secondary Outcome(s)
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NIHSS, mRS
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Source(s) of Monetary Support
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franklin Dike
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Ethics review
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Status: Approved
Approval date: 29/10/2014
Contact:
Uyo Institute of Health Research Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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