In this episode of PsyQ, we review the landmark STEP-BD randomized controlled trial evaluating the effectiveness of adjunctive antidepressant treatment for bipolar depression. We analyze the study's methodology, specifically the use of equipoise-stratified randomization to mirror routine clinical care and the selection of "durable recovery"—defined as eight consecutive weeks of euthymia—as the primary outcome measure. The discussion focuses on the key data points demonstrating that the addition of standard antidepressants (bupropion or paroxetine) to mood stabilizers provided no statistically significant benefit over placebo in achieving durable recovery. Furthermore, we examine the safety findings, which indicated that adjunctive antidepressant use was not associated with an increased risk of treatment-emergent affective switch compared to mood stabilizers alone.
References
Sachs GS, Nierenberg AA, Calabrese JR, et al. Effectiveness of Adjunctive Antidepressant Treatment for Bipolar Depression. N Engl J Med. 2007;356(17):1711-1722.
