Cognitive Dysfunction in MDD Patients

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03187093
• Other study ID #: 11031215
• Status: Recruiting
• Phase: Phase 4
• Start date: October 2016
• Est. completion date: April 2019

Study information

• Verified date: January 2019
• Source: State Institution, Zaporizhzhia Medical Academy of Post-Graduate Education Ministry of Health of Ukraine
• Contact: Oleg A. Levada, MD, ScD
• Phone: +380672623972
• Email: olevada[@]zmapo.edu.ua
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Vortioxetine
10-20 mg once daily for 8 weeks
• Escitalopram
10-20 mg once daily for 8 weeks

Locations

Country	Name	City	State
Ukraine	State Institution "Zaporizhzhia Medical Academy of Postgraduate Education Ministry of Health of Ukraine"	Zaporizhzhia

Sponsors (1)

Lead Sponsor	Collaborator
Oleg Levada

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to week 8 in Sheehan Disability Scale		Baseline to Week 8
Secondary	Change from baseline to week 8 in MADRS		Baseline to Week 8
Secondary	Change from baseline to week 8 in PHQ-9		Baseline to Week 8
Secondary	Change from baseline to week 8 in CGI-S		Baseline to Week 8
Secondary	Change from baseline to week 8 in PDQ-5-D		Baseline to Week 8
Secondary	Change from baseline to week 8 in RAVLT		Baseline to Week 8
Secondary	Change from baseline to week 8 in TMT-B		Baseline to Week 8
Secondary	Change from baseline to week 8 in DSST		Baseline to Week 8
Secondary	Change from baseline to week 8 in plasma levels of IGF-1		Baseline to Week 8
Secondary	Change from baseline to week 8 in plasma levels of BDNF		Baseline to Week 8
Secondary	Change from baseline to week 8 in plasma levels of CRP		Baseline to Week 8
Secondary	Change from baseline to week 8 in plasma levels of cortisol		Baseline to Week 8
Secondary	Change from baseline to week 8 in plasma levels of ACTH		Baseline to Week 8