Cognitive Dysfunction in MDD Patients

Oleg Levada150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Major Depressive Disorder

Interventions

VortioxetineDRUG

10-20 mg once daily for 8 weeks

EscitalopramDRUG

10-20 mg once daily for 8 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

Zaporizhzhya, Ukraine

RECRUITING