Vortioxetine, a multimodal antidepressant for generalized anxiety disorder: A systematic review and meta-analysis

Chi Un Pae, Sheng Min Wang, Changsu Han, Soo Jung Lee, Ashwin A. Patkar, Praksh S. Masand, Alessandro Serretti

Research output: Contribution to journalReview articlepeer-review

45 Citations (Scopus)


Vortioxetine has a beneficial pharmacological profile for reducing anxiety and depression. Recently, a number of randomized, double-blind, placebo-controlled clinical trials (RCTs) of vortioxetine have been conducted in patients with generalized anxiety disorder (GAD); however, the results from GAD RCTs are inconsistent. With an extensive search of databases and clinical trial registries, four published short-term RCTs were identified and included in the present meta-analysis. The mean change in total scores on the Hamilton Anxiety Rating Scale (HAMA) from baseline was the primary endpoint. The secondary endpoints included the response and remission rates, as defined by a ≥50% reduction in HAMA total scores and a ≤7 change in the HAMA total score at the end of treatment. In addition, the mean change in the HAMA total score from baseline in the subgroup with a HAMA total score ≥25 at baseline was included. Vortioxetine was significantly more effective than was placebo, with a standardized mean difference (SMD) of-0.118 (95% CIs,-0.203 to-0.033, P=0.007). In particular, those with severe GAD (HAMA total score ≥25 at baseline) had a significantly greater benefit from vortioxetine than those without (SMD=-0.338, 95% CIs=-0.552 to-0.124, p=0.002). The odds ratios (ORs) for vortioxetine for response and remission were 1.221 (95% CIs, 1.027 to 1.452, P=0.024) and 1.052 (95% CIs, 0.853 to 1.296, P=0.637), respectively. Discontinuation due to adverse events (AEs) (OR=1.560, 1.006 to 2.419, p=0.047) was marginally higher in vortioxetine than placebo treatment, whereas discontinuation due to any reason (OR=0.971, 0.794 to 1.187, p=0.771) and inefficacy (OR=0.687, 0.380 to 1.243, p=0.215) were not significantly different among treatment groups. Although our results suggest that vortioxetine may have a potential as an another treatment option for GAD (especially for severe GAD), they should be interpreted and translated into clinical practice with caution, as the meta-analysis was based on a limited number of RCTs.

Original languageEnglish
Pages (from-to)88-98
Number of pages11
JournalJournal of Psychiatric Research
Publication statusPublished - 2015 May 1
Externally publishedYes

Bibliographical note

Funding Information:
This study was supported by a grant of the Korean Health Technology R&D Project, Ministry of Health & Welfare, Republic of Korea ( HI12C0003 ).

Funding Information:
This work was supported by a grant from the Ministry of Health and Welfare (HI12C0003); however, the funding source had no further role in preparation, data collection, and writing of the paper.

Publisher Copyright:
© 2015 Elsevier Ltd.


  • Efficacy
  • Generalized anxiety disorder
  • Meta-analysis
  • Safety
  • Tolerability
  • Vortioxetine

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Biological Psychiatry


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