| Trial name or title |
Fluoxetine Or Control Under Supervision ‐ Poland |
| Methods |
Study type: interventional (clinical trial)
Estimated enrolment: 200 participants
Allocation: randomised
Intervention model: parallel assignment
Masking: double (participant, care provider)
Primary purpose: treatment |
| Participants |
Country: Poland
Setting: inpatient
Inclusion criteria:
Age ≥ 18 years· Ischaemic or haemorrhagic stroke confirmed by neuroimaging Within 2 to 15 days from the stroke onset Evidence of neurological deficit at randomisation Upper limb functional before stroke
Exclusion criteria:
Subarachnoid haemorrhage (except when secondary to intracerebral bleeding) History of upper limb paresis. A high probability that the patient will not be available during the follow‐up examination after 12 months Patient or carer or both unable to understand spoken or written Polish language (e.g. aphasia hindering communication) Scoring in NIHSS in subsection 1a > 1 point Presence of life‐threatening illness Pregnancy, breastfeeding or reproductive age with no oral contraceptives Epileptic seizures Suicide attempt or self‐harm Allergic or other contraindications to the use of fluoxetine Taking a monoamine oxidase inhibitor for the last 5 weeks prior to enrolment Current or recent depression (up to 6 months) that requires treatment with selective serotonin reuptake inhibitors (SSRIs) Participation in another clinical trial or other evaluation of a medical product (relative contraindication) -
For participants with new upper limb paresis and being considered for TMS the following exclusion criteria
Presence of devices containing metal components in the immediate vicinity of the coil discharge (e.g. cochlear implants, brain stimulators, infusion pumps, pacemakers) History of craniotomy Use of drugs with central or myorelaxant effect (barbiturates, benzodiazepines, myorelaxants, inhalation and intravenous anaesthetics, antiepileptic drugs, antidepressants, neuroleptic)
Aiming to recruit 200 participants |
| Interventions |
Fluoxetine 20 mg daily (1 capsule) for 6 months (180 capsules) vs placebo |
| Outcomes |
The primary outcomes
mRS at 1, 3, 6 and 12 months after the stroke MEP parameters at 1 and after 3 months (in participants who have received TMS only) Brunnstrom scale Medical Research Council scale
Secondary endpoints
Stroke Impact Scale EuroQol 5D‐5L MHI‐5 Diagnosis of depression Compliance with drug intake NIHSS at baseline, 1, 3, 6 and 12 months on BI BDNF at baseline, 1 and 3 months. Treatment effects and the occurrence of possible adverse reactions are assessed up to 12 months
|
| Starting date |
December 2014 |
| Contact information |
jbemenek@o2.pl
czlonkow@ipin.edu.pl |
| Notes |
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