Cognitive Dysfunction in MDD Patients

Study Overview
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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.

Official Title
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Cognitive Dysfunction in Patients With Major Depressive Disorder, Clinical Peculiarities, Biological Markers, and Treatment Efficacy

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Vortioxetine
* Drug: Escitalopram


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vortioxetine<br> | Drug: Vortioxetine<br>* 10-20 mg once daily for 8 weeks<br>* Other names: Trintellix;|
| Active Comparator: Escitalopram<br> | Drug: Escitalopram<br>* 10-20 mg once daily for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to week 8 in Sheehan Disability Scale |  | Baseline to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change from baseline to week 8 in TMT-B |  | Baseline to Week 8 | 
| Change from baseline to week 8 in DSST |  | Baseline to Week 8 | 
| Change from baseline to week 8 in plasma levels of IGF-1 |  | Baseline to Week 8 | 
| Change from baseline to week 8 in plasma levels of BDNF |  | Baseline to Week 8 | 
| Change from baseline to week 8 in plasma levels of CRP |  | Baseline to Week 8 | 
| Change from baseline to week 8 in plasma levels of cortisol |  | Baseline to Week 8 | 
| Change from baseline to week 8 in plasma levels of ACTH |  | Baseline to Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDD, Vortioxetine, Cognitive dysfunction, IGF-1, BDNF, Functioning