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Wednesday, May 7, 2008

Elderly Refuse Clinical Trials

A failed randomized controlled trial of Fluoxetine versus placebo in elderly stroke survivors due to reluctance and subsequent informal discussions by their treating physicians. Also due in part to high community prescribing rates of antidepressants by general practitioners. In a recent research showed that 15% of adults aged over 75 years are in receipt of an antidepressant prescription from their general practitioner, half of them for more than 2 years and many without formal review.

So adolescents your not alone. Elderly are not alone as well, in The Netherlands it was hard to find elderly for a study that would test the efficacy of ECT versus nortrityline among depressed elderly (> 59 years) who had not responded to sertraline, a selective serotonin reuptake inhibitor (SSRI).

Now I am a strong supporter of placebo controlled trials. An important factor for success is the believe physicians and other health workers have in the importance of the trial. If the health workers are ambivalent you can forget it.

Why is a placebo controlled trial important for stroke survivors?
The authors:

However, the evidence that antidepressants are effective is surprisingly weak, and although there is some indication that they produce improvement in mood symptoms we know little about speciļ¬c indications or about complications of treatment. The latter are especially important since if treatment of depression is to have an impact on rehabilitation outcomes, then it needs to be given early at which time complications
may be more likely.

Despite screening 641 patients they could only include 1 patient, so they gave up but nevertheless got their experience published, good for them as well as for the editors of the International Journal of Geriatric Psychiatry.
Ruddell, M., Spencer, A., Hill, K., House, A. (2007). Fluoxetinevs placebo for depressive symptoms after stroke: failed randomised controlled trial. International Journal of Geriatric Psychiatry, 22(10), 963-965. DOI: 10.1002/gps.1771

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