Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Fluoxetine on Motor Rehabilitation After Ischemic Stroke (FLAME)

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Toulouse Identifier:
First received: April 8, 2008
Last updated: September 15, 2011
Last verified: July 2009
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.

Condition Intervention Phase
Ischemic Stroke
Motor Impairment
Drug: fluoxetine
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of 3 Months Daily Treatment With Selective Serotonin Reuptake Inhibitor (SSRI, Fluoxetine) on Motor Rehabilitation After Ischemic Stroke. FLAME Trial

Resource links provided by NLM:

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Progression in the Fugl-Meyer Motor Scale [ Time Frame: M3 (3 months) ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: March 2005
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: fluoxetine
fluoxetine per os 20 mg daily
Other Name: PROZAC
Placebo Comparator: 2
Drug: placebo
placebo per os daily

Detailed Description:

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.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00657163

University Hospital
Besançon, France, 25030
University Hospital René Dubos
Cergy-Pontoise, France, 95303
University Hospital
Dijon, France, 21000
University Hospital
Grenoble, France, 38048
University Hospital
Nantes, France, 44093
University Hospital Pitié Salpétrière
Paris, France, 75651
University Hospital Sainte Anne
Paris, France, 75674
University Hospital Rangueil
Toulouse, France, 31052
University Hospital Purpan
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Principal Investigator: François Chollet, PhD University Hospital, Toulouse
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital, Toulouse Identifier: NCT00657163     History of Changes
Other Study ID Numbers: 0300501
French PHRC
Study First Received: April 8, 2008
Last Updated: September 15, 2011

Keywords provided by University Hospital, Toulouse:
Stroke recovery
Pharmacological modulation
Selective Serotonin Reuptake Inhibitor (SSRI)
Brain plasticity
Ischemic Stroke and Motor impairment
Modulation of recovery and cerebral plasticity by Fluoxetine

Additional relevant MeSH terms:
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Serotonin Receptor Agonists
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors processed this record on April 28, 2017