title: Vortioxetine: a New Treatment for Major Depressive Disorder.
abstract: BACKGROUND
  Vortioxetine is a structurally novel medication that has recently been approved for treatment of major depressive disorder (MDD). This medication is a serotonin reuptake inhibitor that also has a number of other potentially relevant effects on serotoninergic receptors, which may differentiate the drug's effects from those of current first-line antidepressants, such as selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs).
  
  
  METHODS
  This article will review the basic clinical pharmacology of vortioxetine, summarize the major clinical trials that were performed prior to approval by the US Food and Drug Administration (FDA), discuss relevant post-marketing studies of this drug, and offer expert commentary on the significance of this new agent in clinical practice. Pre-approval studies were identified as all randomized, placebo-controlled studies of vortioxetine listed on clinicaltrials.gov. Other referenced studies were identified via a MEDLINE database literature search in August 2015 using the key search terms, vortioxetine and Lu AA21004, combined with additional terms that included pharmacological profile, pharmacokinetics, drug interactions, adverse effects, side effects, safety, major depression, and major depressive disorder. We identified relevant systematic reviews, meta-analyses, randomized trials and preclinical studies of importance.
  
  
  CONCLUSIONS
  Results of placebo-controlled trials suggest efficacy and an overall safety profile comparable to existing first-line antidepressants. The most common side effects are nausea, vomiting and constipation. Results of several studies indicate that vortioxetine may have therapeutic effects on cognition (e.g., memory and executive functioning) that exceed that of standard antidepressants. Disadvantages include cost and the current paucity of long-term efficacy data from large clinical trials. The authors suggest that vortioxetine is currently a good second-line antidepressant option and shows promise, pending additional long-term data, to become a first-line antidepressant option.
authors.affiliation: a Philadelphia Veterans Affairs Medical Center , Philadelphia , PA , 19104 , USA.|b Department of Psychiatry , University of Pennsylvania , Philadelphia , PA 19104 , USA.
authors.forename: K Ryan
authors.initials: KR
authors.lastname: Connolly
authors.affiliation: a Philadelphia Veterans Affairs Medical Center , Philadelphia , PA , 19104 , USA.|b Department of Psychiatry , University of Pennsylvania , Philadelphia , PA 19104 , USA.
authors.forename: Michael E
authors.initials: ME
authors.lastname: Thase
mesh_terms: D000818:Animals; D000928:Antidepressive Agents / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*; D003248:Constipation / Q000139:chemically induced; D003865:Major Depressive Disorder / Q000188:drug therapy*; D006801:Humans; D009325:Nausea / Q000139:chemically induced; D010879:Piperazines / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D017367:Selective Serotonin Reuptake Inhibitors / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*; D013440:Sulfides / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*; D014839:Vomiting / Q000139:chemically induced; D000078784:Vortioxetine
chemical_list: D000928:Antidepressive Agents; D010879:Piperazines; D017367:Selective Serotonin Reuptake Inhibitors; D013440:Sulfides; D000078784:Vortioxetine
keywords: Vortioxetine; antidepressants; major depressive disorder (MDD); multimodal serotonin modulator; selective serotonin reuptake inhibitors (SSRIs); serotonin norepinephrine reuptake inhibitors (SNRIs)