NCT03187093
Unknown
Phase 4
Cognitive Dysfunction in Patients With Major Depressive Disorder, Clinical Peculiarities, Biological Markers, and Treatment Efficacy
Oleg Levada1 site in 1 country150 target enrollmentOctober 2016
ConditionsMajor Depressive Disorder
Overview
- Phase
- Phase 4
- Intervention
- Vortioxetine
- Conditions
- Major Depressive Disorder
- Sponsor
- Oleg Levada
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Change from baseline to week 8 in Sheehan Disability Scale
- Last Updated
- 7 years ago
Overview
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.
Investigators
Oleg Levada
MD, ScD (psychiatry), PhD (neurology), Psychiatry course chief
State Institution, Zaporizhzhia Medical Academy of Post-Graduate Education Ministry of Health of Ukraine
Eligibility Criteria
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
Arms & Interventions
Vortioxetine
Intervention: Vortioxetine
Escitalopram
Intervention: Escitalopram
Outcomes
Primary Outcomes
Change from baseline to week 8 in Sheehan Disability Scale
Time Frame: Baseline to Week 8
Secondary Outcomes
- 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 CGI-S(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)
Study Sites (1)
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