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Vortioxetine Monotherapy for Major Depressive Disorder in Type 2 Diabetes

NCT03580967 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2022-11-29

No results posted yet for this study

Summary

This study will enroll participants who have been diagnosed with type 2 diabetes and are experiencing symptoms of depression. This study will look at an anti-depressant medication called vortioxetine (Trintellix). Vortioxetine is an oral medication (pill) that has been approved by the US Food and Drug Administration (FDA) to treat depression in adults.

The purpose of this study is to look at what effects (if any) vortioxetine may have on symptoms of depression in patients with type 2 diabetes. This study will also look at what effects (if any) vortioxetine has on blood sugar, and how vortioxetine may improve the way our brains are able to adapt and respond to stress.

Conditions

Interventions

DRUG

Vortioxetine

Oral pill to be taken daily for 8 weeks, 10 or 20 mg dosage. Participants who cannot tolerate this dose may be reduced to 5mg dose.

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Todd Doyle

    lead OTHER

Principal Investigators

  • Todd Doyle, PhD · Loyola University Chicago

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2021-07-01
Completion
2021-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03580967 on ClinicalTrials.gov