Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of 3 Months Daily Treatment With Selective Serotonin Reuptake Inhibitor (SSRI, Fluoxetine) on Motor Rehabilitation After Ischemic Stroke. FLAME Trial
Brief Summary: Recovery from stroke is a major process and, except for acute intravenous thrombolysis, no treatment able to enhance recovery has yet been validated. Some drugs may have a positive effect when combined with physical rehabilitation. Previous studies have shown a potential effect of catecholaminergic drugs on cerebral plasticity of stroke patients. In 2001, our group has demonstrated in a small group of stroke patients (n=8) that a single dose of fluoxetine (Selective Serotonin Reuptake Inhibitor - SSRI) improved motor performance and modulated cerebral plasticity. We conducted a phase IIb prospective, double-blind, randomized, placebo controlled study to assess the effect of a daily treatment with fluoxetin (20 mg) on motor performance in patients with mild to severe motor deficit after ischemic stroke.


Options:
A: Inclusion Criteria:

* First ever ischemic stroke
* Age 18 years or above

Exclusion Criteria:

* Hemorrhagic stroke
* Dementia or other neurodegenerative disease
* Antidepressant medical treatment within 6 months of admission
* Acute need for antidepressant treatment
* Drug abuse or other conditions that may indicate noncompliant behavior
* Liver failure (increased liver enzyme levels up to or more than 2 times upper limit)
* Renal failure (eGFR below 30 ml/min per 1.73m2)
* Hyponatremia (S-potassium below 130 mmol/l)
* Actively bleeding ulcer
* Fatal stroke or other severe co-morbidity that markedly decreases expected life span
* Prolonged corrected QT-interval (QTc above 480 ms)
* Ongoing treatment with drugs known to prolong the QTc interval
B: Inclusion Criteria:

* Adults older than 20 years
* Patients with acute stroke (ischemic stroke or cerebral hemorrhage) confirmed by neuroimaging within 21 days after stroke onset
* Patients with hemorrhagic transformation of infarcted tissue will not be included, but if investigators judge the risk of bleeding is small (i.e., reduced amount of blood in follow-up neuroimaging) those patients can be enrolled.
* Patients with MRS ≥ 2 on screening
* Patients without definite history of depression
* Patients who fulfill the following criteria in the K-MADRS test:

The combined score of the 9th question (pessimistic thoughts) and the 10th question (suicidal idea) ≤ 7 The score of the 10th question \< 6

* Patients without serious communication problem
* Patients who agree to participate in this trial

Exclusion Criteria:

* Patients with MRS 0 or 1 on screening
* Patients who have definite history of depression or have taken antidepressants
* Patients who have been diagnosed as having bipolar disorder or other psychiatric disorders
* Patients with severe dementia or aphasia. However, those who have motor aphasia but are still communicable can be enrolled
* Patients who have taken migraine medication on screening or those who are expected to take migraine medication frequently due to severe migraine
* Patients who have strong suicidal idea on screening test or those who express their wish to be treated for depression
* Patients who are considered to be treated for depression by charged physicians
* Patients who need SSRI medication for other reasons
* Patients who have taken antiepileptic drugs on screening
* Patients who have a history of traumatic brain injury, brain tumor, or other brain disease (except stroke) within 30 days prior to screening
* Patients with uncommon causes of stroke (e.g. subarachnoid hemorrhage, venous thrombosis, arteriovenous malformation, or Moyamoya disease)
* Patients with bleeding diathesis, hemophilia, or thrombocytopenia
* Patients with severe concomitant illness (e.g. liver disease, renal disease, malignancy)
* Patients with abnormal blood tests Abnormal LFT (ALT \> 200 or AST \> 200) Anemia (Hb \< 8 mg/dl) or thrombocytopenia (\<100,000/mm3) Renal insufficiency (Cr \> 3.0 mg/dl) or renal failure requiring dialysis Patients with severe heart failure (NYHA class III or IV) NYHA classification for heart failure Class I : patients with no limitation of activities; they suffer no symptoms from Ordinary activities Class II : patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion Class III : patients with marked limitation of activity; they are comfortable only at rest Class IV : patients who should be at complete rest, confined to bed or chair; any activity brings on
* Pregnant or lactating patients
* Patients who are participating in another clinical trial, but those who are participating in the observational study can be enrolled
C: Inclusion Criteria:

* Stroke within the last 120 days

Exclusion Criteria:

* DSM (Diagnostic and Statistical Manual) IV criteria for major or minor depressive disorder
* Heart, respiratory, kidney, or liver failure; severely disabling musculoskeletal disorder; or cancer
* Diagnosis of neurodegenerative disorders such as Parkinson's disease, Alzheimer's disease, Multiple System Atrophy, or Huntington's disease
* Pre-existing dementia or aphasia with severe language comprehension deficits
* Alcohol or substance abuse or dependence within the last 12 months
* Recurrent unipolar or bipolar disorder prior to the stroke
D: Inclusion Criteria:

* Men and women aged from 18 to 85
* No motor relapse from a previous stroke
* Inclusion from day 5 to day 10 after stroke
* Ischemic stroke with unilateral motor deficit
* Motor NIHSS ≥ 5 on the affected side of the body
* NIHSS \< 20
* Fugl Meyer Motor Scale \<55
* Modified Rankin Scale between 1 and 5
* Informed consent obtained from the subject or a member of his family

Exclusion Criteria:

* Pregnant or breast-feeding woman
* Woman able to procreate without valid contraception
* Subject protected by law
* Concomitant disease with unfavourable prognosis within 1 year
* Drug addiction
* Allergy to fluoxetine
* Hepatic failure (TGO and TGP \>2N)
* Permanent Renal failure (Creatinin \>180micromol/l)
* Patients treated by tricyclic antidepressant, selective serotonin reuptake inhibitor, monoamine oxidase inhibitor (IMAO), and neuroleptics in the past month
* Depression requiring pharmacological treatment
* Previous stroke with motor relapse
* Fugl Meyer Motor Scale \> 55
* Modified Rankin Scale = 0 or 6
* Patients needing carotid surgery within 3 months
* Aphasia preventing correct evaluation of motor and depression scales.

Answer: D