Cognitive Dysfunction in MDD Patients
- Registration Number
- NCT03187093
- Lead Sponsor
- Oleg Levada
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vortioxetine Vortioxetine - Escitalopram Escitalopram -
- Primary Outcome Measures
Name Time Method Change from baseline to week 8 in Sheehan Disability Scale Baseline to Week 8
- Secondary Outcome Measures
Name Time Method 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 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 CGI-S 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
Trial Locations
- Locations (1)
State Institution "Zaporizhzhia Medical Academy of Postgraduate Education Ministry of Health of Ukraine"
🇺🇦Zaporizhzhia, Ukraine