Efficacy, safety and tolerability of Symbyax for acute-phase management of
treatment-resistant depression.
Author(s): Bobo WV, Shelton RC.
Affiliation(s): Department of Psychiatry, Vanderbilt University School of Medicine, South Suite
2200, Village at Vanderbilt, Nashville, TN 37212, USA.
william.v.bobo@vanderbilt.edu
Publication date & source: 2010, Expert Rev Neurother. , 10(5):651-70
Treatment resistance is frequently encountered during the long-term care of
patients with major depression. A number of 'next step' therapeutic options exist
in such cases, including switching to an alternative antidepressant, combining
antidepressants from different pharmacological classes, adding evidence-supported
psychotherapies to ongoing antidepressant treatment and augmentation with a
nonantidepressant drug. Augmenting antidepressants with atypical antipsychotic
drugs has generated considerable clinical interest. Three atypical antipsychotics
(aripiprazole, quetiapine and olanzapine) have received regulatory approval for
adjunctive use with antidepressants for treatment-resistant major depression
(TRD) in adults. Symbyax (olanzapine-fluoxetine combination or OFC), the
combination of olanzapine and the selective serotonin-reuptake inhibitor
fluoxetine, is also approved for this indication. The short-term effectiveness of
OFC for TRD is supported by results of five published randomized, controlled,
acute-phase studies of generally similar design. In each study, OFC was
associated with rapid reduction in depressive symptoms. In two studies,
significantly greater improvement in depressive symptoms occurred in OFC-treated
patients at study end point compared with those who received antidepressant
monotherapy. These effects appeared to be strongest in cases where antidepressant
failure was established during the current depressive episode. Although OFC was
well-tolerated, increases in body weight and prolactin concentration were greater
with OFC than antidepressant monotherapy, and were similar to olanzapine
monotherapy. Increases in random total cholesterol levels were greatest for OFC,
and were significantly greater than those of olanzapine and antidepressant
monotherapy. The long-term efficacy and tolerability of OFC for TRD has not been
investigated, and the comparative effectiveness of OFC versus other next-step
options is unknown. As such, the exact place of OFC among the available
therapeutic options for TRD is not fully understood at this time.
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