| Trial name or title |
Efficacy oF Fluoxetine – a randomisEd Controlled Trial in Stroke (EFFECTS) |
| Methods |
Multicentre RCT
Study type: interventional (clinical trial)
Estimated enrolment: 1500 participants
Allocation: randomised
Intervention model: parallel assignment
Masking: quadruple (participant, care provider, investigator, outcomes assessor)
Primary purpose: treatment |
| Participants |
Sweden
Inclusion criteria
Age ≥ 18 Informed consent can only be obtained from a patient who according to the trial investigator is mentally capable of decision‐making and who, after having received information and got answers to their questions, wants to participate in the trial Brain imaging is compatible with intracerebral haemorrhage or ischaemic stroke Randomisation can be performed between 2 and 15 days after stroke onset and by the research group at the person's local/emergency hospital Persisting focal neurological deficit is present at the time of randomisation severe enough to warrant treatment from the physicians and the patient's and relative's perspective
Exclusion criteria
Subarachnoidal haemorrhage (except where secondary to a primary intracerebral haemorrhage) Unlikely to be available for follow‐up for the next 12 months e.g. no fixed home address Unable to speak Swedish and no close family member available to help with follow‐up forms Other life‐threatening illness (e.g. advanced cancer) that will make 12‐month survival unlikely History of epileptic seizures History of allergy or contraindications to fluoxetine Pregnant or breastfeeding Previous drug overdose or attempted suicide Already enrolled into a CTIMP Current or recent (within the last month) depression requiring treatment with an SSRI antidepressant Current use of medications which have serious interactions with fluoxetine Use of any MAOI during the last 5 weeks
Aiming to recruit 1500 participants |
| Interventions |
Fluoxetine (20 mg once daily) for 6 months with oral capsules |
| Outcomes |
Outcomes collected at 6 months and 12 months
Primary outcome
Secondary outcomes
Death from all causes HRQoL (EQ5D‐5L) Depression and anxiety (MHI 5) Level of fatigue (vitality subscale of the Health Questionnaire) Recovery from stroke (SIS) New diagnosis of depression since randomisation Adverse events (including participant‐completed diary) Health and social care utilisation Adherence to trial medication Motor function (NIHSS) Aphasia (NIHSS), aphasia (Norsk Grunntest for Afasi) Depression (MADRS + DSM‐IV/DSM‐V) Cognitive function (Montreal Cognitive Assessment (MoCA))
|
| Starting date |
20 October 2014 |
| Contact information |
Associate Professor Erik Lundström, Department of Neuroscience, Neurology, Uppsala University, Akademiska sjukhuset, 751 85 Uppsala, Sweden. Email: erik.lundstrom@neuro.uu.se. |
| Notes |
clinicaltrials.gov/ct2/show/NCT02683213 |
