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Alert!! Do Not Give Children Antidepressant Drugs Study Shows!! |
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 Alert!! Do Not Give Children Antidepressant Drugs!!
Study Shows Medication No More Effective Than Placebo!
Source: http://medicine.plosjournals.org Date: 02/28/08
Background.
Everyone feels miserable occasionally. But for some people—those with
depression—these sad feelings last for months or years and interfere with daily life. Depression is a serious medical
illness caused by imbalances in the brain chemicals that regulate mood.
It affects one in six people at some time during their life, making
them feel hopeless, worthless, unmotivated, even suicidal. Doctors
measure the severity of depression using the “Hamilton Rating Scale of
Depression” (HRSD), a 17–21 item questionnaire. The answers to each
question are given a score and a total score for the questionnaire of
more than 18 indicates severe depression. Mild depression is often
treated with psychotherapy or talk therapy (for example,
cognitive–behavioral therapy helps people to change negative ways of
thinking and behaving). For more severe depression, current treatment
is usually a combination of psychotherapy and an antidepressant drug,
which is hypothesized to normalize the brain chemicals that affect
mood. Antidepressants include “tricyclics,” “monoamine oxidases,” and
“selective serotonin reuptake inhibitors” (SSRIs). SSRIs are the newest
antidepressants and include fluoxetine, venlafaxine, nefazodone, and
paroxetine.
Why Was This Study Done?
Although the US Food and Drug
Administration (FDA), the UK National Institute for Health and Clinical
Excellence (NICE), and other licensing authorities have approved SSRIs
for the treatment of depression, some doubts remain about their
clinical efficacy. Before an antidepressant is approved for use in
patients, it must undergo clinical trials that compare its ability to
improve the HRSD scores of patients with that of a placebo, a dummy
tablet that contains no drug. Each individual trial provides some
information about the new drug's effectiveness but additional
information can be gained by combining the results of all the trials in
a “meta-analysis,” a statistical method for combining the results of
many studies. A previously published meta-analysis of the published and
unpublished trials on SSRIs submitted to the FDA during licensing has
indicated that these drugs have only a marginal clinical benefit. On
average, the SSRIs improved the HRSD score of patients by 1.8 points
more than the placebo, whereas NICE has defined a significant clinical
benefit for antidepressants as a drug–placebo difference in the
improvement of the HRSD score of 3 points. However, average improvement
scores may obscure beneficial effects between different groups of
patient, so in the meta-analysis in this paper, the researchers
investigated whether the baseline severity of depression affects
antidepressant efficacy.
What Did the Researchers Do and Find?
The researchers obtained data on all
the clinical trials submitted to the FDA for the licensing of
fluoxetine, venlafaxine, nefazodone, and paroxetine. They then used
meta-analytic techniques to investigate whether the initial severity of
depression affected the HRSD improvement scores for the drug and
placebo groups in these trials. They confirmed first that the overall
effect of these new generation of antidepressants was below the
recommended criteria for clinical significance. Then they showed that
there was virtually no difference in the improvement scores for drug
and placebo in patients with moderate depression and only a small and
clinically insignificant difference among patients with very severe
depression. The difference in improvement between the antidepressant
and placebo reached clinical significance, however, in patients with
initial HRSD scores of more than 28—that is, in the most severely
depressed patients. Additional analyses indicated that the apparent
clinical effectiveness of the antidepressants among these most severely
depressed patients reflected a decreased responsiveness to placebo
rather than an increased responsiveness to antidepressants.
What Do These Findings Mean?
These findings suggest that,
compared with placebo, the new-generation antidepressants do not
produce clinically significant improvements in depression in patients
who initially have moderate or even very severe depression, but show
significant effects only in the most severely depressed patients. The
findings also show that the effect for these patients seems to be due
to decreased responsiveness to placebo, rather than increased
responsiveness to medication. Given these results, the researchers
conclude that there is little reason to prescribe new-generation
antidepressant medications to any but the most severely depressed
patients unless alternative treatments have been ineffective. In
addition, the finding that extremely depressed patients are less
responsive to placebo than less severely depressed patients but have
similar responses to antidepressants is a potentially important insight
into how patients with depression respond to antidepressants and
placebos that should be investigated further.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050045.
Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration
Irving Kirsch1*, Brett J. Deacon2, Tania B. Huedo-Medina3, Alan Scoboria4, Thomas J. Moore5, Blair T. Johnson3
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