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Pharmacy & Health News


News category: General News  Posted on Tuesday, May 22nd, 2007

According to the latest research, patients suffering bipolar disorder will not receive treatment benefit by adding an antidepressant medication to a typical mood stabilizer such as lithium.

The findings of this study indicate that treating patients with a mood stabilizer alone is preferable, a recommendation that goes against common practice.

"We are convinced that at the outset of your therapy, it is very sensible to have this ‘mood-stabilizer- optimized’ sort of approach, and what we have learned from this research is that it really makes sense to give that some time to work," explained Dr Gary Sachs, lead author of the research, director of the bipolar clinic and research program at Massachusetts General Hospital and associate professor of psychiatry at Harvard Medical School in Boston.

No profit from antidepros

"The patient loses nothing from that," Sachs said. "We did not demonstrate that any group got benefits from having antidepressant medicines added."

On the other hand, though, doubling the amount of medications did not confer any risk, Sachs and his colleagues reported in the March 29 issue of the New England Journal of Medicine.

Nevertheless, treating bipolar disorder is never a one-size-fits-all proposition.

No one size fits all

"It is very difficult to judge at the individual level due to individual variation," explained Dr Christopher Colenda, dean of the Texas A&M Health Science Centre College of Medicine in College Station. "As a treating clinician, you can try a single therapy for a while and, if it is not effective, add the antidepressant medication. This research gives us a rational place to begin and to make clinically significant decisions."

A very characteristic feature of bipolar disorder is alternating swings of very high and very low - or depressed - moods, together with alterations in energy and the ability to function.

The typical of care for bipolar disorder is the treatment with such a mood stabilizer as lithium, valproate, carbamazepine or other medicines decreasing mania.

Even though antidepressant drugs have never been approved for the treatment of bipolar disorder, and even though there is restricted evidence as to their safety and effectiveness, such medicines are widely prescribed apart from a mood stabilizer.

May activate manic episodes

Nevertheless, a lot of scientists are worried that antidepressant medications may even activate a manic episode in bipolar patients.

"This practice is extremely common," Sachs explained. "The researchers agreed that the number one priority was resolving this issue, due to the fact that there are two competing expert suggestions: a stabilizer plus an antidepressant drug or a stabilizer alone. We posed the question, ‘Would two be better than one only?’ "

This experiment a teamwork with the US National Institutes of Mental Health, randomly assigned 336 participants suffering bipolar disorder from "real world," clinical settings to take a mood stabilizer plus either an antidepressant drug (bupropion/Wellbutrin or paroxetine/Aropax) or a placebo.

After nearly 26 weeks, 23.5 per cent of individuals taking antidepressant medicines had remained well for at least eight weeks in a row against 27.3 per cent of patients taking a placebo. The difference was not statistically important.

No benefit and no problems

"In this research, we do not demonstrate a benefit nor a problem caused by antidepressant drugs," Sachs explained. "We didn’t demonstrate anything to gain. Moreover, we didn’t confirm any harm, and there may well be individual patients who might react to antidepressant medications and individual antidepressant drugs that really work better."

Furthermore, around ten per cent of each group - with or without antidepressant drugs - experienced the beginning of mania.

Sachs was astonished by such results. "I was convinced that antidepressant medications activated mania," he said. "This is a significant finding of the research. That’s a real thing I have to take to heart."

Another specialist said that the research could alter the way in which physicians think.

"Treatment has to be individualized, however, for the substantial majority of patients, antidepressant medications do not offer important benefit and may carry high risk," explained Dr Richard Weisler, adjunct professor of psychiatry at the University of North Carolina at Chapel Hill and adjunct associate professor of psychiatry at Duke University Medical Centre in Durham, North Carolina.

Rethink necessary

Another research has indicated that antidepressant medications do come with their own hazards, and, "if you’ve got those risks and little benefit, then we have to be rethinking how the majority of clinicians are really treating bipolar," Weisler said.

Next week, the findings concerning the results of psychosocial treatments used in the trial will be presented. And there will probably be many more papers from this set of data, Sachs added.





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