Antidepressant medication and pregnancy: time for randomized controlled trials

Despite the high prevalence of depression and the fairly common use of anti-depressant drugs during pregnancy, no randomized controlled treatment trials (RCTs) prospectively assess the efficacy and safety of antidepressant drugs in depressed pregnant women and then the subsequent effect of drug exposure (versus placebo exposure) on the neonate and later on the child's development. Observational studies are used to determine whether a drug exposure during pregnancy is associated with an adverse outcome, but they include various confounding factors and other sources of bias. Systematic reviews and meta-analyses, as well as published guidelines from various organizations, all analyze, interpret, and emphasize the same data somewhat differently, and they do not provide consistent or unequivocal guidance for patients or prescribers. Whether antidepressant drugs are efficacious in pregnant women; whether any or certain antidepressant drugs are harmful to the fetus, neonate, or developing child; and whether untreated depression itself is harmful are uncertainties that should now be addressed in rigorous, well-designed, prospective RCTs.