The Relationship Among Changes in Brain Network Activation in Adult Outpatients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to explore patterns of Brain Network Activation (BNA) changes
      from baseline to endpoint on 1) efficacy of core symptoms of Major Depressive Disorder (MDD)
      and 2) improvement of cognitive dysfunction with acute treatment with flexible dose
      vortioxetine in adult outpatients with MDD and subjective complaints of cognitive
      dysfunction.
    

Detailed description: 
      Vortioxetine is a novel antidepressant with hypothetical multimodal mechanism of action. It
      is thought to work through a combination of multiple pharmacological modes of action: 5-HT
      (hydroxytryptamine, or serotonin) reuptake inhibition, 5-HT3 (hydroxytryptamine, or
      serotonin) and 5-HT7 (hydroxytryptamine, or serotonin) receptor antagonism, 5-HT1A
      (hydroxytryptamine, or serotonin) receptor agonism, and 5-HT1B (hydroxytryptamine, or
      serotonin) receptor partial agonism. In vivo nonclinical studies have demonstrated that
      vortioxetine enhances levels of the neurotransmitters 5-HT (hydroxytryptamine, or serotonin),
      norepinephrine (NE), dopamine (DA), acetylcholine and histamine in specific areas of the
      brain. These affinities are all considered to be of clinical relevance and involved in the
      mechanism of action at therapeutic doses.

      Vortioxetine has been shown to improve core depressive symptoms and improve cognitive
      function in adult outpatients with MDD and subjective complaints of cognitive function. This
      pilot study is intended to evaluate the extent to which BNA technology can provide clinically
      valuable information and provide information toward designing a subsequent confirmatory study
      that will further elucidate the effect of vortioxetine on MDD and cognitive function in this
      population. This exploratory study will ascertain the acute changes in core depression
      symptoms, cognitive function, tolerability, and safety using flexible-dose vortioxetine in
      adult outpatients with MDD with subjective complaints of cognitive functioning, as measured
      by BNA changes and standard outcome measures for depression and cognition.

      The study consists of 8 weeks of open-label treatment for MDD with response to treatment
      measured by standard research depression scales and BNA electroencephalogram (EEG) readings
      taken at certain points during the trial. An important aim in this study is to explore what
      correlations may exist between changes in measured brainwave patterns and reported change in
      depressive symptoms
    

Intervention name(s): vortioxetine
Intervention type(s): Drug
Intervention description(s): Open-label vortioxetine
Intervention MeSH terms: Vortioxetine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: depression; brain network activation; vortioxetine