"Evaluation by Transcranial Magnetic Stimulation of the Benefit of Fluoxetine on Motor Recovery After Stroke" "EFLUSTIM"

Terminated

Phase N/A Results N/A

Update History

13 Feb '16
The eligibility criteria were updated.
New
Inclusion Criteria: - Man and women, aged from 18 to 80 years. - Social security affiliation - Inclusion from day 3 to day 15 after stroke or brain haemorrhage - Hemiparesia with upper limb motor deficit (Fugl-Meyer score - hand < or = 10) - Informed consent Exclusion Criteria: - Score NIHSS > 20 - Depression (criteria DSM5-R) with MADRS score > 19 - History of recurrent bipolar or depressive disorders. - History of behavior or suicidal idea - Family history of extension of the interval QT or congenital long interval QT - History of clinical stroke - Aphasia preventing correct evaluation of motor and depression scales. - Patients treated by antidepressant drugs, monoamine oxidase inhibitor (IMAO), and neuroleptics in the past month - Benzodiazepines within 48 hours preceding inclusion. - Intolerance or allergy to fluoxetine (Sandoz® 20 mg pill) - Severe swallowing disorders preventing oral administration of the treatment - Planned carotid surgery - Pregnant or breast-feeding woman - Hepatic failure (TGO and TGP >2N); severe renal failure (creatinine >180micromol/l) - Concomitant severe disease not allowing follow-up. - Participation to another therapeutic study. - Contraindication to MRI and TMS
Old
Inclusion Criteria: - Man and women, aged from 18 to 80 years. - Social security affiliation - Inclusion from day 3 to day 15 after stroke or brain haemorrhage - Hemiparesia with upper limb motor deficit (Fugl-Meyer score - hand < or = 10) - Informed consent Exclusion Criteria: - Score NIHSS > 20 - Depression (criteria DSM5-R) with MADRS score > 19 - History of recurrent bipolar or depressive disorders. - History of behavior or suicidal idea - Family history of extension of the interval QT or congenital long interval QT - History of clinical stroke - Aphasia preventing correct evaluation of motor and depression scales. - Patients treated by antidepressant drugs, monoamine oxidase inhibitor (IMAO), and neuroleptics in the past month - Benzodiazepines within 48 hours preceding inclusion. - Intolerance or allergy to fluoxetine (Sandoz® 20 mg pill) - Severe swallowing disorders preventing oral administration of the treatment - Planned carotid surgery - Pregnant or breast-feeding woman - Hepatic failure (TGO and TGP >2N); severe renal failure (creatinine >180micromol/l) - Concomitant severe disease not allowing follow-up. - Participation to another therapeutic study. - Contraindication to MRI and TMS
13 Jun '15
A location was updated in Paris.
New
The overall status was removed for Centre Hospitalier Sainte-Anne.
3 Mar '15
The eligibility criteria were updated.
New
Inclusion Criteria: - Man and women, aged from 18 to 80 years. - Social security affiliation - Inclusion from day 3 to day 15 after stroke or brain haemorrhage - Hemiparesia with upper limb motor deficit (Fugl-Meyer score - hand < or = 10) - Informed consent Exclusion Criteria: - Score NIHSS > 20 - Depression (criteria DSM5-R) with MADRS score > 19 - History of recurrent bipolar or depressive disorders. - History of behavior or suicidal idea - Family history of extension of the interval QT or congenital long interval QT - History of clinical stroke - Aphasia preventing correct evaluation of motor and depression scales. - Patients treated by antidepressant drugs, monoamine oxidase inhibitor (IMAO), and neuroleptics in the past month - Benzodiazepines within 48 hours preceding inclusion. - Intolerance or allergy to fluoxetine (Sandoz® 20 mg pill) - Severe swallowing disorders preventing oral administration of the treatment - Planned carotid surgery - Pregnant or breast-feeding woman - Hepatic failure (TGO and TGP >2N); severe renal failure (creatinine >180micromol/l) - Concomitant severe disease not allowing follow-up. - Participation to another therapeutic study. - Contraindication to MRI and TMS
Old
Inclusion Criteria: - Man and women, aged from 18 to 75 years. - Social security affiliation - Inclusion from day 5 to day 15 after stroke - Hemiparesia with upper limb motor deficit (Fugl-Meyer score - upper limb < or = 45/66) - Patient able to walk - Informed consent Exclusion Criteria: - Score NIHSS > 20 - Depression (criteria DSM5-R) with MADRS score > 19 - History of recurrent bipolar or depressive disorders. - History of clinical stroke - Aphasia preventing correct evaluation of motor and depression scales. - Patients treated by antidepressant drugs, monoamine oxidase inhibitor (IMAO), and neuroleptics in the past month - Benzodiazepines within 48 hours preceding inclusion. - Intolerance or aallergy to fluoxetine - Severe swallowing disorders preventing oral administration of the treatment - Planned carotid surgery - Pregnant or breast-feeding woman - Hepatic failure (TGO and TGP >2N); severe renal failure (creatinine >180micromol/l) - Concomitant severe disease not allowing follow-up. - Participation to another therapeutic study. - Contraindication to MRI and TMS
A location was updated in Paris.
New
The overall status was removed for Centre Hospitalier Sainte-Anne.