Cognitive Dysfunction in MDD Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03187093
• Date of registration: 01/06/2017
• Prospective Registration: No
• Primary sponsor: Oleg Levada
• Public title: Cognitive Dysfunction in MDD Patients
• Scientific title: Cognitive Dysfunction in Patients With Major Depressive Disorder, Clinical Peculiarities, Biological Markers, and Treatment Efficacy
• Date of first enrolment: October 2016
• Target sample size: 150
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03187093
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Ukraine

Contacts

• Name: Alexandra Troyan, MD

• Name: Oleg A. Levada, MD, ScD

Key inclusion & exclusion 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

- Cognitive or language impairment of such severity as to adversely affect the
performance of tests



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Major Depressive Disorder

Intervention(s)

Drug: Vortioxetine

Drug: Escitalopram

Primary Outcome(s)

Change from baseline to week 8 in Sheehan Disability Scale [Time Frame: Baseline to Week 8]

Secondary Outcome(s)

Change from baseline to week 8 in MADRS [Time Frame: Baseline to Week 8]

Change from baseline to week 8 in plasma levels of cortisol [Time Frame: Baseline to Week 8]

Change from baseline to week 8 in CGI-S [Time Frame: Baseline to Week 8]

Change from baseline to week 8 in DSST [Time Frame: Baseline to Week 8]

Change from baseline to week 8 in RAVLT [Time Frame: Baseline to Week 8]

Change from baseline to week 8 in PDQ-5-D [Time Frame: Baseline to Week 8]

Change from baseline to week 8 in plasma levels of ACTH [Time Frame: Baseline to Week 8]

Change from baseline to week 8 in PHQ-9 [Time Frame: Baseline to Week 8]

Change from baseline to week 8 in plasma levels of IGF-1 [Time Frame: Baseline to Week 8]

Change from baseline to week 8 in plasma levels of BDNF [Time Frame: Baseline to Week 8]

Change from baseline to week 8 in TMT-B [Time Frame: Baseline to Week 8]

Change from baseline to week 8 in plasma levels of CRP [Time Frame: Baseline to Week 8]

Secondary ID(s)

11031215

Source(s) of Monetary Support

Please refer to primary and secondary sponsors