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Vortioxetine for MDD, Cognition, and Systemic Inflammatory Biomarkers

NCT02637466 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2016-09-30

No results posted yet for this study

Summary

The purpose of this antidepressant study is to determine the efficacy of vortioxetine on depression and cognition in 80 women with breast cancer, and to elucidate inflammatory-mediated mechanisms by which depression and its treatment influence cancer outcome. Our hypothesis is that effective vortioxetine antidepressant therapy in depressed women with breast cancer will attenuate increased intermediate endpoints of inflammation that contribute to the pathogenesis of depression, cognitive impairment, and cancer progression

Conditions

  • Unipolar Major Depression
  • Stage I, II or III Breast Cancer

Interventions

DRUG

Vortioxetine

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • University of Miami

    lead OTHER

Principal Investigators

  • Dominique Musselman, M.D., MSCR · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2018-07-31
Completion
2019-07-31

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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 NCT02637466 on ClinicalTrials.gov