Cognitive Dysfunction in MDD Patients

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

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.

Study Overview

• Status: Unknown
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Vortioxetine; Drug: Escitalopram

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Ukraine
  • Zaporizhzhia, Ukraine, 69096
    • Recruiting
    • State Institution "Zaporizhzhia Medical Academy of Postgraduate Education Ministry of Health of Ukraine"
    • Contact: Alexandra Troyan, MD; Phone Number: +380673287519; Email: troian@zmapo.edu.ua

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Escitalopram	Drug: Escitalopram; 10-20 mg once daily for 8 weeks
Active Comparator: Vortioxetine	Drug: Vortioxetine; 10-20 mg once daily for 8 weeks; Other Names: Brintellix; Trintellix

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Oleg Levada

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: June 1, 2017
• First Submitted That Met QC Criteria: June 13, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Actual): January 10, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: MDD; BDNF; IGF-1; Functioning; Vortioxetine; Cognitive dysfunction
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Neurocognitive Disorders; Cognition Disorders; Depression; Depressive Disorder; Cognitive Dysfunction; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin Antagonists; Anti-Anxiety Agents; Antidepressive Agents, Second-Generation; Serotonin 5-HT3 Receptor Antagonists; Citalopram; Vortioxetine
• Other Study ID Numbers: 11031215

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes