Major Depressive DisorderPhase 4NCT03187093
Cognitive Dysfunction in MDD Patients
A Phase 4 study testing Vortioxetine and Escitalopram in people with Major Depressive Disorder, run by Oleg Levada at 1 site in Ukraine.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Vortioxetine and Escitalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUkraine
- Study dates
- Oct 2016to Apr 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Ukraine1 site, 1 recruiting
- Recruiting
State Institution "Zaporizhzhia Medical Academy of Postgraduate Education Ministry of Health of Ukraine"
Zaporizhzhya, 69096
Alexandra Troyan, MD, +380673287519, troian@zmapo.edu.ua
About this study
Official title: 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Vortioxetine, Escitalopram
- Keywords
- MDD, Vortioxetine, Cognitive dysfunction, IGF-1, BDNF, Functioning
- Medical subject headings
- Depressive Disorder, Major, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VortioxetineDrug
Also called Brintellix, Trintellix
10-20 mg once daily for 8 weeks
EscitalopramDrug
10-20 mg once daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vortioxetine | Active comparator | Not described Receives: Drug: Vortioxetine |
| Escitalopram | Active comparator | Not described Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to week 8 in Sheehan Disability Scale
Measured: Baseline to Week 8
Secondary outcomes (12)
Change from baseline to week 8 in MADRS
Measured: Baseline to Week 8
Change from baseline to week 8 in PHQ-9
Measured: Baseline to Week 8
Change from baseline to week 8 in CGI-S
Measured: Baseline to Week 8
Change from baseline to week 8 in PDQ-5-D
Measured: Baseline to Week 8
Change from baseline to week 8 in RAVLT
Measured: Baseline to Week 8
Change from baseline to week 8 in TMT-B
Measured: Baseline to Week 8
Change from baseline to week 8 in DSST
Measured: Baseline to Week 8
Change from baseline to week 8 in plasma levels of IGF-1
Measured: Baseline to Week 8
Change from baseline to week 8 in plasma levels of BDNF
Measured: Baseline to Week 8
Change from baseline to week 8 in plasma levels of CRP
Measured: Baseline to Week 8
Change from baseline to week 8 in plasma levels of cortisol
Measured: Baseline to Week 8
Change from baseline to week 8 in plasma levels of ACTH
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study startOct 2016
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oleg Levada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Oleg Levada, State Institution, Zaporizhzhia Medical Academy of Post-Graduate Education Ministry of Health of Ukraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187093
- Sponsor's protocol ID
- 11031215
- Status last verified
- Jan 2019
- First submitted
- 1 Jun 2017
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 32384884
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Dysfunction in Patients With Major Depressive Disorder, Clinical Peculiarities, Biological Markers, and Treatment Efficacy
- ClinicalTrials.gov ID
- NCT03187093
- Acronym / sponsor ID
- 11031215
- Conditions
- Major Depressive Disorder
- Keywords
- MDD, Vortioxetine, Cognitive dysfunction, IGF-1, BDNF, Functioning
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Oleg LevadaUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vortioxetine | Active comparator | Drug: Vortioxetine |
| Escitalopram | Active comparator | Drug: Escitalopram |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VortioxetineAlso: Brintellix, Trintellix10-20 mg once daily for 8 weeks | Drug | Vortioxetine |
| Escitalopram10-20 mg once daily for 8 weeks | Drug | Escitalopram |
Primary outcome
Change from baseline to week 8 in Sheehan Disability Scale
Time frame: Baseline to Week 8
12 secondary outcomes
Change from baseline to week 8 in MADRS
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 CGI-S
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 RAVLT
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 DSST
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 plasma levels of CRP
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 plasma levels of ACTH
Time frame: Baseline to Week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Derived from this study: PubMed 32384884Levada 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vortioxetine and Escitalopram in people with Major Depressive Disorder, run by Oleg Levada at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oleg A. Levada, MD, ScD (+380672623972, olevada@zmapo.edu.ua), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to week 8 in Sheehan Disability Scale (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03187093, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019; AzTrials last refreshed its copy on 29 Oct 2026.