Cognitive Dysfunction in MDD Patients

Oleg Levada

Status and phase

Unknown

Phase 4

Conditions

Major Depressive Disorder

Treatments

Drug: Escitalopram

Drug: Vortioxetine

Study type

Interventional

Funder types

Other

Identifiers

NCT03187093

11031215

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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