“I think we’ve made decisions (about how to treat depression) more difficult,” says co-author Robert DeRubeis, a psychologist at the University of Pennsylvania. The findings are published in today’s Journal of the American Medical Association. “I hope we have.”
ANTIDEPRESSANTS: Number of Americans taking them doubles
Antidepressants are among the most-prescribed drugs in the USA. More than 164 million prescriptions were dispensed in 2008, according to IMS Health.
DeRubeis’ team pooled data from six trials in which a total of 718 depressed patients were randomly assigned to take either an antidepressant or a placebo. The authors obtained patient-specific data from scientists involved with each trial.
Antidepressants were more effective than a placebo only for patients with very severe depression, who made up 40% of trial participants but, according to a recent survey cited in DeRubeis’ paper, represent fewer than 30% of depressed people who seek treatment in the real world.
“The health establishment needs to take stock and ask about costs and benefits” of antidepressants, DeRubeis says. Meanwhile, he says, his study “should give one pause” about prescribing antidepressants to mildly, moderately or even severely depressed patients. Instead, he says, doctors might want to consider non-drug options, such as exercise or psychotherapy.
In a statement, Food and Drug Administration spokeswoman Karen Riley called DeRubeis’ paper “useful.”
“But every patient is different, and translating these findings into clinical practice is yet another challenge,” Riley added. “Some modestly ill patients will still benefit from drug treatment, while some very severely ill patients will not.”
A larger study published in February 2008 reached conclusions similar to those in DeRubeis’ paper. In the 2008 study, researchers pooled data from all clinical trials submitted to the FDA for the licensing of Prozac, Serzone (no longer on the market), Effexor and Paxil.
Such findings “demonstrate a failure in the system: These drugs were not thoroughly tested in mild to moderate depression prior to their approval,” says Thomas Moore, a senior scientist at the Institute for Safe Medication Practices in Horsham, Pa., and co-author of the 2008 paper. “Any new antidepressants should be.”