Cognitive Dysfunction in MDD Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vortioxetine

Group Type ACTIVE_COMPARATOR

Vortioxetine

Intervention Type DRUG

10-20 mg once daily for 8 weeks

Escitalopram

Group Type ACTIVE_COMPARATOR

Escitalopram

Intervention Type DRUG

10-20 mg once daily for 8 weeks

Interventions

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Vortioxetine

10-20 mg once daily for 8 weeks

Intervention Type DRUG

Escitalopram

10-20 mg once daily for 8 weeks

Intervention Type DRUG

Other Intervention Names

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Brintellix Trintellix

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes