The Relationship Among Changes in Brain Network Activation in Adult Outpatients With Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title: Relationship Among Changes in Brain Network Activation, Changes in Core Depressive and Cognitive Symptoms and Safety and Tolerability in Adults With Major Depressive Disorder Treated With Open-label, Flexible-dose Vortioxetine

Status Not yet recruiting

Clinical Trial Summary

The purpose of this study is to explore patterns of BNA changes from baseline to endpoint on 1) efficacy of core MDD symptoms and, 2) improvement of cognitive dysfunction with acute treatment of flexible dose vortioxetine in adult outpatients with MDD and subjective complaints of cognitive dysfunction.

Clinical Trial 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 reuptake inhibition, 5-HT3 and 5-HT7 receptor antagonism, 5-HT1A receptor agonism, and 5-HT1B receptor partial agonism [43]. In vivo nonclinical studies have demonstrated that vortioxetine enhances levels of the neurotransmitters 5-HT, NE, DA, acetylcholine and histamine in specific areas of the brain [43]. 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 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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

• NCT number: NCT02559947
• Study type: Interventional
• Source: Psychiatric Medicine Associates, L.L.C.
• Contact: Michael E Topel, PsyD
• Phone: 847-679-8000
• Email: michael_topel@rush.edu
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 2015
• Completion date: October 2018