Back to resultsCognitive Dysfunction in MDD Patients
Primary Purpose
Major Depressive Disorder
Status
Unknown status
Phase
Phase 4
Locations
Ukraine
Study Type
Interventional
Intervention
Vortioxetine
Escitalopram
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring MDD, Vortioxetine, Cognitive dysfunction, IGF-1, BDNF, Functioning
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
- Cognitive or language impairment of such severity as to adversely affect the performance of tests
Sites / Locations
- State Institution "Zaporizhzhia Medical Academy of Postgraduate Education Ministry of Health of Ukraine"Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Vortioxetine
Escitalopram
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline to week 8 in Sheehan Disability Scale
Secondary Outcome Measures
Change from baseline to week 8 in MADRS
Change from baseline to week 8 in PHQ-9
Change from baseline to week 8 in CGI-S
Change from baseline to week 8 in PDQ-5-D
Change from baseline to week 8 in RAVLT
Change from baseline to week 8 in TMT-B
Change from baseline to week 8 in DSST
Change from baseline to week 8 in plasma levels of IGF-1
Change from baseline to week 8 in plasma levels of BDNF
Change from baseline to week 8 in plasma levels of CRP
Change from baseline to week 8 in plasma levels of cortisol
Change from baseline to week 8 in plasma levels of ACTH
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03187093
Brief Title
Cognitive Dysfunction in MDD Patients
Official Title
Cognitive Dysfunction in Patients With Major Depressive Disorder, Clinical Peculiarities, Biological Markers, and Treatment Efficacy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (Actual)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
April 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Oleg Levada
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
MDD, Vortioxetine, Cognitive dysfunction, IGF-1, BDNF, Functioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vortioxetine
Arm Type
Active Comparator
Arm Title
Escitalopram
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Vortioxetine
Other Intervention Name(s)
Brintellix, Trintellix
Intervention Description
10-20 mg once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Intervention Description
10-20 mg once daily for 8 weeks
Primary Outcome Measure Information:
Title
Change from baseline to week 8 in Sheehan Disability Scale
Time Frame
Baseline to Week 8
Secondary Outcome Measure Information:
Title
Change from baseline to week 8 in MADRS
Time Frame
Baseline to Week 8
Title
Change from baseline to week 8 in PHQ-9
Time Frame
Baseline to Week 8
Title
Change from baseline to week 8 in CGI-S
Time Frame
Baseline to Week 8
Title
Change from baseline to week 8 in PDQ-5-D
Time Frame
Baseline to Week 8
Title
Change from baseline to week 8 in RAVLT
Time Frame
Baseline to Week 8
Title
Change from baseline to week 8 in TMT-B
Time Frame
Baseline to Week 8
Title
Change from baseline to week 8 in DSST
Time Frame
Baseline to Week 8
Title
Change from baseline to week 8 in plasma levels of IGF-1
Time Frame
Baseline to Week 8
Title
Change from baseline to week 8 in plasma levels of BDNF
Time Frame
Baseline to Week 8
Title
Change from baseline to week 8 in plasma levels of CRP
Time Frame
Baseline to Week 8
Title
Change from baseline to week 8 in plasma levels of cortisol
Time Frame
Baseline to Week 8
Title
Change from baseline to week 8 in plasma levels of ACTH
Time Frame
Baseline to Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Cognitive or language impairment of such severity as to adversely affect the performance of tests
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oleg A. Levada, MD, ScD
Phone
+380672623972
Email
olevada@zmapo.edu.ua
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra Troyan
Phone
+380673287519
Email
troian@zmapo.edu.ua
Facility Information:
Facility Name
State Institution "Zaporizhzhia Medical Academy of Postgraduate Education Ministry of Health of Ukraine"
City
Zaporizhzhia
ZIP/Postal Code
69096
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Troyan, MD
Phone
+380673287519
Email
troian@zmapo.edu.ua
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32384884
Citation
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.
Results Reference
derived
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Cognitive Dysfunction in MDD Patients
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