NCT03187093

Brief Summary

Major Depressive Disorder (MDD) is one of the most prevalent mental diagnosis within the worldwide population. Although there is evidence about relationship between MDD and cognitive dysfunction, still the correlations between biomarkers and the severity of the disorder or the level of cognitive dysfunction need further research. Therefore, the aim of the study is to determine such relationships in Ukrainian population.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4 major-depressive-disorder

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

2.5 years

First QC Date

June 1, 2017

Last Update Submit

January 8, 2019

Conditions

Major Depressive Disorder

Keywords

MDDVortioxetineCognitive dysfunctionIGF-1BDNFFunctioning

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to week 8 in Sheehan Disability Scale

    Baseline to Week 8

Secondary Outcomes (12)

  • Change from baseline to week 8 in MADRS

    Baseline to Week 8

  • Change from baseline to week 8 in PHQ-9

    Baseline to Week 8

  • Change from baseline to week 8 in CGI-S

    Baseline to Week 8

  • Change from baseline to week 8 in PDQ-5-D

    Baseline to Week 8

  • Change from baseline to week 8 in RAVLT

    Baseline to Week 8

  • +7 more secondary outcomes

Study Arms (2)

Vortioxetine

ACTIVE COMPARATOR
Drug: Vortioxetine

Escitalopram

ACTIVE COMPARATOR
Drug: Escitalopram

Interventions

VortioxetineDRUG

10-20 mg once daily for 8 weeks

Also known as: Brintellix, Trintellix
Vortioxetine
EscitalopramDRUG

10-20 mg once daily for 8 weeks

Escitalopram

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatient 18 to 65 years of age
  • Meets DSM-5 criteria for MDD
  • Depressive episode duration ≥ 2 months
  • The participant has MARDS total score ≥ 7
  • Free of psychotropic medications for at least 5 half-lives before baseline
  • Fluent in Russian/Ukrainian

You may not qualify if:

  • Current diagnosis or history of manic/hypomanic episode
  • Any other psychiatric diagnosis that is considered the primary diagnosis
  • Any significant personality disorder diagnosis
  • High suicidal risk, defined by clinician judgment
  • Substance dependence/abuse in the past year
  • Significant neurological disorders, head trauma, or other unstable medical conditions
  • History of endocrinological diseases
  • Pregnant or breastfeeding
  • Psychosis in the current episode
  • High risk for hypomanic switch
  • Cognitive or language impairment of such severity as to adversely affect the performance of tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Institution "Zaporizhzhia Medical Academy of Postgraduate Education Ministry of Health of Ukraine"

Zaporizhzhia, 69096, Ukraine

RECRUITING

Related Publications (1)

  • Levada OA, Troyan AS, Pinchuk IY. Serum insulin-like growth factor-1 as a potential marker for MDD diagnosis, its clinical characteristics, and treatment efficacy validation: data from an open-label vortioxetine study. BMC Psychiatry. 2020 May 8;20(1):208. doi: 10.1186/s12888-020-02636-7.

    PMID: 32384884DERIVED

MeSH Terms

Conditions

Depressive Disorder, MajorCognitive Dysfunction

Interventions

VortioxetineEscitalopram

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersCognition DisordersNeurocognitive Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Oleg A. Levada, MD, ScD

CONTACT

+380672623972olevada@zmapo.edu.ua

Alexandra Troyan

CONTACT

+380673287519troian@zmapo.edu.ua

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, ScD (psychiatry), PhD (neurology), Psychiatry course chief

Study Record Dates

First Submitted

June 1, 2017

First Posted

June 14, 2017

Study Start

October 1, 2016

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

January 10, 2019

Record last verified: 2019-01

Locations

UA(1)