NCT02969876

Pattern Separation, Brain Derived Neurotrophic Factors, and Mechanisms of Vortioxetine

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study is a 6-week, proof-of-concept, open trial of vortioxetine for 20 patients with major depressive disorder.

Detailed description

The U.S. Food and Drug Administration approved vortioxetine to treat major depressive disorder in 2013. Researchers believe vortioxetine may improve pattern separation and pattern completion (i.e., a neurological function) in people with major depressive disorder; thus, this research study aims to determine how vortioxetine increases a person's ability to think. The current study is an open label trial, therefore, all participants will receive vortioxetine. Furthermore, participants receive the vortioxetine at no cost. It will take participants 6 weeks to complete this study. Participants are asked to come to the Mass General Hospital campus for 1 screening visit which includes a full psychiatric evaluation, and 5 additional study visits. During study visits, participants will meet with a clinician and then complete computer based cognitive tests.

Conditions

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

Interventions

Type	Name	Description
DRUG	Vortioxetine	Vortioxetine is a selective serotonin re-uptake inhibitor (SSRI), a common form of treatment for major depressive disorder.

Timeline

• Start date: 2017-08-24
• Primary completion: 2018-08-06
• Completion: 2018-08-06
• First posted: 2016-11-21
• Last updated: 2019-10-14
• Results posted: 2019-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study