Assessment oF FluoxetINe In sTroke recoverY (AFFINITY) trial

Phase 3

• Conditions: Stroke; Stroke - Ischaemic; Stroke - Haemorrhagic

• Registration Number: ACTRN12611000774921
• Lead Sponsor: Sir Charles Gairdner Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-22
• Study Completion: 2020-08-03
• Last Update Posted: 22 February 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 1280

Inclusion Criteria

Men or women aged 18 years or more with: - Clinical diagnosis of stroke 2-15 days previously (Day of stroke onset = Day 0, randomise on Day 2-15); - Brain imaging consistent with ischaemic or haemorrhagic (intracerebral and/or subarachnoid) stroke (including normal CT brain scan); - Persisting measurable focal neurological deficits (e.g. motor, somatosensory, visual, language, cognitive) present at randomisation and severe enough to produce a modified Rankin Scale (mRS) score of equal or > 1 and to warrant treatment from the perspective of patient or carer(s).

Exclusion Criteria

Exclusion Criteria
Any of the following:
History of epileptic seizures
History of bipolar disorder
History of drug overdose or attempted suicide
Ongoing treatment with any selective serotonin reuptake inhibitor (SSRI)
Allergy or contra indication to fluoxetine including
Hepatic impairment (serum alanine aminotransferase [ALT] >120 U/l),
Renal impairment (creatinine >180micromol/l or eGFR < 30ml/min/1.73m2),
Hyponatremia (sodium <125mmol/L) despite treatment of the cause and confirmed on repeat testing,
Use of medications that may interact seriously with fluoxetine
Proposed use of a monoamine oxidase inhibitor (MAOI), or use of a MAOI within 14 days prior to randomisation
Current treatment with an antipsychotic drug (neuroleptic), pimozide, tamoxifen, or tramadol, unless the patient, doctor and if possible prescribing doctor, believe it is appropriate to discontinue use.
Not available for follow up over the next 365 days e.g. no fixed home address.
Life-threatening illness (e.g. advanced cancer) that is likely to reduce 365 day survival
Pregnant, breast-feeding or of child-bearing potential and not using contraception
Enrolled in another interventional clinical research trial involving an investigational product (medicine) or device

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional outcome as measured by the mRS using the simplified modified Rankin Scale questionnaire (smRSq) at 180 days after randomisation [Baseline, 1 month, 3 months, 6 months, 12 months ]