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.
We project to include in the study a maximum of 168 patients with a recent (5 to 10 days) ischemic stroke and unilateral motor deficit in order to obtain 100 completed patients. Nine stroke centers in France are involved. Each patient will receive daily, during three months, 20 mg of fluoxetin or placebo. Patients will be evaluated at inclusion, day 30, M3 (3 months), M12.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
fluoxetine per os 20 mg daily
placebo per os daily
University Hospital
Besançon, France
University Hospital René Dubos
Cergy-Pontoise, France
University Hospital
Dijon, France
University Hospital
Grenoble, France
University Hospital
Nantes, France
University Hospital Pitié Salpétrière
Paris, France
University Hospital Sainte Anne
Paris, France
University Hospital Rangueil
Toulouse, France
University Hospital Purpan
Toulouse, France
Progression in the Fugl-Meyer Motor Scale
Time frame: M3 (3 months)
Fugl-Meyer Stroke Scale
Time frame: M12 (12 months)
NIH stroke scale
Time frame: M3 and M12
MADRS depression scale
Time frame: M3 and M12
Modified Rankin scale
Time frame: M3 and M12
Mortality
Time frame: M3 and M12
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