Fluoxetine on Motor Rehabilitation After Ischemic Stroke

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Treatments: Fluoxetine; Serotonin; Serotonin Uptake Inhibitors

Criteria

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.