Vortioxetine superior to placebo for improving depression, anxiety, cognition in MDD

Vortioxetine more effectively improved depression, anxiety and cognition than placebo, according to study results published in Journal of Clinical Psychiatry.

“Previous meta-analyses of vortioxetine have focused on symptomatic improvements or changes in cognitive function (such as those measured by the Digit Symbol Substitution Test [DSST]) and involved pooling all available data existing at the time,” Nadia Iovieno, MD, of the department of psychiatry at Massachusetts General Hospital and Harvard Medical School, and colleagues wrote. “These prior meta-analyses yielded evidence of efficacy for vortioxetine in depression. The purpose of the present work was to build upon previous analyses to include newer studies, but also to broaden and deepen our understanding of the efficacy of this compound across symptoms and according to individual study performance.”

To do so, the researchers conducted a meta-analysis of studies of vortioxetine (Trintellix, Takeda/Lundbeck) among adults with major depressive disorder. They used PubMed to identify studies by cross-referencing vortioxetine with placebo and randomized, and they applied no language or publication year restrictions. Specifically, they included 17 randomized, double-blind, placebo-controlled clinical trials that compared oral vortioxetine monotherapy with placebo as acute MDD treatment. Included studies had 7,269 total participants, of whom 3,630 and 3,639 were randomly assigned to vortioxetine or placebo, respectively. Iovieno and colleagues used a pre-coded form for data extractions, which included number of patients randomly assigned, treatment group, Montgomery-Asberg Depression Rating Scale (MADRS) response and remission rates, and mean change in scores from baseline and standard errors for the MADRS, Hamilton Anxiety Rating Scale (HARS) and DSST.

Results showed the probability of placebo receipt did not predict difference in change in MADRS scores between vortioxetine and placebo (P = .54). The researchers reported a standardized mean difference for change in MADRS score for vortioxetine overall compared with placebo of 0.33, as well as 0.24, 0.33, 0.26 and 0.44 for 5 mg, 10 mg, 15 mg and 20 mg doses, respectively. They noted greater difference in efficacy between drug and placebo in studies with a low vs. a high placebo response rate.

“Vortioxetine is effective in treating depression, anxiety and cognitive symptoms,” the researchers wrote. “Placebo responders may have led previous studies to underestimate the efficacy of vortioxetine.”