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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vortioxetine | Active Comparator |
| |
| Escitalopram | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine | Drug | 10-20 mg once daily for 8 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to week 8 in Sheehan Disability Scale | Baseline to Week 8 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oleg A. Levada, MD, ScD | Contact | +380672623972 | olevada@zmapo.edu.ua | |
| Alexandra Troyan | Contact | +380673287519 | troian@zmapo.edu.ua |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Institution "Zaporizhzhia Medical Academy of Postgraduate Education Ministry of Health of Ukraine" | Recruiting | Zaporizhzhia | 69096 | Ukraine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32384884 | Derived | 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. |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
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| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011437 | Propylamines |
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| Escitalopram | Drug | 10-20 mg once daily for 8 weeks |
|
| 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 |
| D019965 |
| Neurocognitive Disorders |
| D000588 |
| Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |