2005-2009年に脳卒中後5-10年後の片麻痺患者118人（Fugl-Meyer motor scale (FMMS) 55以下）にプロザックまたはプラセーボを３ヶ月投与し、運動機能を評価したところ、プラセーボの24.3に比べてプロザック服用群は平均34.0点であった。自立できる人が多く、うつも少なかった。
Prozac shows promise in recovery from stroke
By Kate Kelland
LONDON | Sun Jan 9, 2011 7:03pm EST
LONDON (Reuters) - Giving the antidepressant drug Prozac to people who have just had a stroke could help them to regain more control over their movements and allow more of them to live independently, scientists said Monday.
In the largest study yet of the effect of this type of antidepressant on stroke recovery, French researchers found that stroke patients given Prozac improved their scores in motor skills tests more than those given a placebo, or dummy pill.
Experts commenting on the findings said they had "enormous potential to change clinical practice" and raised the question of whether most stroke patients with motor skill problems should be treated with this relatively cheap type of antidepressant.
Stroke is the single largest cause of adult disability and the third-largest cause of death in the developed world.
The cost of caring for its victims, who often have motor function difficulties like paralysis or weakness on one side, puts a heavy burden on already stretched healthcare systems.
A few previous small trials had already suggested that giving drugs like Prozac, which belongs to a drug class known as selective serotonin re-uptake inhibitors (SSRIs), might improve motor skill recovery after stroke.
Prozac was developed by Eli Lilly and is now available in a cheaper generic form as fluoxetine.
Hemiplegia -- paralysis to one side of the body -- and hemiparesis -- weakness on one side of the body -- are the most common disabilities after stroke and scientists believe SSRIs might help improve movement by increasing the level of the brain chemical serotonin in the central nervous system.
"The positive effect of the drug on motor function... suggests that the neuronal ... action of SSRIs provides a new pathway that should be explored further," said Francois Chollet of Toulouse University Hospital, who led this research.
In the study, conducted between March 2005 and June 2009 and published in The Lancet Neurology journal Monday, 118 patients in France were given either Prozac or a placebo for three months starting between five and 10 days after they had suffered a stroke.
All patients were also given physiotherapy, and had their motor skills tested at the start of the trial and on day 90.
Significantly greater improvements in motor function were recorded after three months in patients taking Prozac, where the average test score improved by 34.0 points, than in the placebo group, where the average improvement was 24.3 points.
There were also more independent patients and depression was less common in the Prozac group than in the placebo group, and side effects of the drug were rare and mild, researchers said.
Commenting on the study, Robert Robinson and Harold Adams from the University of Iowa in the United States, said it could change the way doctors treat stroke victims in future, but more research is needed to see if the effects continue over time.
Roger Bonomo, director of stroke care at Lenox Hill Hospital in New York, said another way to look at the implications of this trial would be as justification for treatment of post-stroke depression before it progresses.
"Depression after stroke is a common enough complication to have raised the question of treating with antidepressants early after stroke," he said in an emailed comment. "If motor function is also more likely to improve, then treating before symptoms of depression emerge is likely to be even more beneficial.
10 January 2011 Last updated at 02:18 GMT
Stroke recovery boosted by a course of Prozac
Giving stroke patients Prozac soon after the event could help their recovery from paralysis, a study has found.
Researchers discovered more improvement in movement and greater independence after three months in patients taking the antidepressant (also known as fluoxetine), compared to placebo.
The Lancet Neurology study was based on research on 118 patients in France.
UK stroke experts said the findings were "promising".
This was the largest study of selective serotonin re-uptake inhibitors (SSRIs) and stroke recovery to date.
Tests on stroke patients 90 days after being given the drug found that patients taking fluoxetine had gained significantly more function in their upper and lower limbs than patients who were not given the drug.
Patients in the fluoxetine group were also more likely to be coping independently.
All patients in the study had moderate to severe motor disabilities following their stroke.
The study noted that the side-effects from the antidepressant were generally mild and infrequent, although this group did notice more instances of nausea and diarrhoea.
Continue reading the main story
It's very interesting to see that this already licensed drug could have a dual benefit”
End Quote Research team
The authors, led by Professor Franc,ois Chollet, said: "The positive effect of the drug on motor function of recovering patients suggests that the... action of SSRIs provides a new pathway that should be explored further in the treatment of acute ischaemic stroke."
Every year in the UK 150,000 people have a stroke and a third of these will be left with a disability such as paralysis down one side of their body.
Dr Sharlin Ahmed, research liaison officer at the UK Stroke Association, said: "We are continually searching for new treatments which can improve the outcomes for stroke survivors and the results of this research look promising.
"Antidepressants, such as fluoxetine, can be used to treat stroke patients with depression which is a common side effect of stroke, so it's very interesting to see that this already licensed drug could have a dual benefit.
"However, further research needs to be undertaken before the use of this antidepressant can be accepted as an effective treatment for improving movement following a stroke."
The Lancet Neurology, Early Online Publication, 10 January 2011
doi:10.1016/S1474-4422(10)70314-8Cite or Link Using DOI
Fluoxetine for motor recovery after acute ischaemic stroke (FLAME): a randomised placebo-controlled trial
Prof Franc,ois Chollet MD a c d Corresponding AuthorEmail Address, Jean Tardy MD a c d, Jean-Franc,ois Albucher MD a c d, Claire Thalamas MD f, Emilie Berard MD b e, Catherine Lamy MD g, Yannick Bejot MD h, Sandrine Deltour MD i, Assia Jaillard MD j, Philippe Niclot MD k, Benoit Guillon MD l, Thierry Moulin MD m, Philippe Marque MD c d, Je're'mie Pariente MD a c d, Catherine Arnaud MD b e, Isabelle Loubinoux PhD c
Hemiplegia and hemiparesis are the most common deficits caused by stroke. A few small clinical trials suggest that fluoxetine enhances motor recovery but its clinical efficacy is unknown. We therefore aimed to investigate whether fluoxetine would enhance motor recovery if given soon after an ischaemic stroke to patients who have motor deficits.
In this double-blind, placebo-controlled trial, patients from nine stroke centres in France who had ischaemic stroke and hemiplegia or hemiparesis, had Fugl-Meyer motor scale (FMMS) scores of 55 or less, and were aged between 18 years and 85 years were eligible for inclusion. Patients were randomly assigned, using a computer random-number generator, in a 1:1 ratio to fluoxetine (20 mg once per day, orally) or placebo for 3 months starting 5―10 days after the onset of stroke. All patients had physiotherapy. The primary outcome measure was the change on the FMMS between day 0 and day 90 after the start of the study drug. Participants, carers, and physicians assessing the outcome were masked to group assignment. Analysis was of all patients for whom data were available (full analysis set). This trial is registered with ClinicalTrials.gov, number NCT00657163.
118 patients were randomly assigned to fluoxetine (n=59) or placebo (n=59), and 113 were included in the analysis (57 in the fluoxetine group and 56 in the placebo group). Two patients died before day 90 and three withdrew from the study. FMMS improvement at day 90 was significantly greater in the fluoxetine group (adjusted mean 34?0 points [95% CI 29?7―38?4]) than in the placebo group (24?3 points [19?9―28?7]; p=0?003). The main adverse events in the fluoxetine and placebo groups were hyponatraemia (two [4%] vs two [4%]), transient digestive disorders including nausea, diarrhoea, and abdominal pain (14 [25%] vs six [11%]), hepatic enzyme disorders (five [9%] vs ten [18%]), psychiatric disorders (three [5%] vs four [7%]), insomnia (19 [33%] vs 20 [36%]), and partial seizure (one [<1%] vs 0).
In patients with ischaemic stroke and moderate to severe motor deficit, the early prescription of fluoxetine with physiotherapy enhanced motor recovery after 3 months. Modulation of spontaneous brain plasticity by drugs is a promising pathway for treatment of patients with ischaemic stroke and moderate to severe motor deficit.
Public French National Programme for Clinical Research.
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