EUCTR2011-006130-16-SE进行中（未招募）不适用
ESTABLISHING THE EFFECT(S) AND SAFETY OF FLUOXETINE INITIATED IN THE ACUTE PHASE OF STROKE
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,550
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age = 18
- •2. 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
- •3. Brain imaging is compatible with intra cerebral haemorrhage or ischaemic stroke
- •4. Randomisation can be performed between 2 and 15 days after stroke onset and by the research group at the patient’s local/emergency hospital.
- •5. 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1250
排除标准
- •1. Subarachnoid haemorrhage (except where secondary to a primary intracerebral haemorrhage).
- •2. Unlikely to be available for follow up for the next 12 months e.g. no fixed home address.
- •3. Unable to speak Swedish and no close family member available to help with follow up forms.
- •4. Other life threatening illness (e.g. advanced cancer) that will make 12-month survival unlikely.
- •5. History of epileptic seizures.
- •6. History of allergy or contraindications to fluoxetine including:
- •a) Hepatic impairment (S-ASAT/ALAT > 3 upper normal limit)
- •b) Renal impairment (S-Creatinine levels > 180 micromol/L)
- •7. Pregnant or breastfeeding, women of childbearing age not taking contraception. Minimum contraception is an oral contraceptive. An HCG-test is to be made prior randomisation and after the end of trial medication
- •8. Previous drug overdose or attempted suicide.
- •9. Already enrolled into a CTIMP.
- •10. Current or recent (within the last month) depression requiring treatment with an SSRI antidepressant.
- •11. Current use of medications which have serious interactions with fluoxetine
- •a) Use of any mono-amino-oxidase inhibitor (MAOI) during the last 5 weeks
- •Co-administration of Fluoxetine and a mono-amino-oxidase inhibitor (MAOI) may result in life threatening interactions. Therefore, patients on MAOI inhibitors are ineligible for the EFFECTS trial. Also, any patient in need of treatment with a MAOI must stop their trial treatment for at least 5 weeks before commencing the MAOI, or to be treated as in-patients by a psychiatrist.
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