Two new antidepressants, escitalopram and duloxetine, have been approved by the FDA since publication of the guideline. Escitalopram, the active S-enantiomer of citalopram, is an SSRI antidepressant that has FDA approval for acute and maintenance treatment of major depressive disorder. Evidence from randomized, clinical trials suggests that escitalopram is superior to placebo in the short-term treatment of depression (21), with efficacy and tolerability comparable to that of other antidepressants, including venlafaxine (22, 23) and citalopram (21, 24).

Duloxetine, a dual serotonin-norepinephrine reuptake inhibitor, has also been approved for the treatment of depression. Randomized, clinical trials show duloxetine to be more efficacious than placebo (25–28) and comparable in efficacy to SSRI antidepressants (27, 28). The drug is generally well tolerated, with reported adverse effects of treatment (e.g., nausea, dry mouth, dizziness, somnolence, insomnia, constipation, and asthenia) varying across studies but typically being infrequent at total oral daily doses of 40–120 mg. In addition to ameliorating core symptoms of depression, duloxetine exhibits efficacy relative to placebo in treating painful physical symptoms (26, 28–31) and anxiety in depressed individuals (32). It also appears to ameliorate pain in the absence of depression (31), and it is FDA indicated for the management of pain associated with diabetic peripheral neuropathy.

Since publication of the guideline, the combination of fluoxetine and olanzapine has received FDA approval on the basis of a randomized, clinical trial supporting its use (33). Although the combination product (brand name Symbyax) is indicated for the treatment of episodes of bipolar depression, combined treatment with fluoxetine and olanzapine has also been found useful in treating episodes of major depression with psychotic features (34) and in treatment-resistant depression (35, 36).

Reboxetine, a selective norepinephrine reuptake inhibitor that was noted in the guideline to be possibly close to receiving approval, is not currently approved for use. Atomoxetine, another selective norepinephrine reuptake inhibitor, has recently become available but is approved for the treatment of attention deficit hyperactivity disorder. Although the possibility of using atomoxetine, either alone or in combination with an SSRI, for the treatment of depression has prompted interest among clinicians, the drug does not have an FDA indication for this use, and data on its use in the treatment of depression are limited (37–39). In addition, the FDA has just added a bolded warning to atomoxetine's labeling noting that the medication should be discontinued in patients who develop jaundice or laboratory evidence of liver injury (http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01335.html).

The evidence cited here on new medications is based on premarketing research. Clinicians are cautioned that real-world experiences after a drug is approved often bring unexpected findings, including less efficacy in some circumstances and unanticipated adverse events.


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