Clinical trial NCT03187093: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: MDD
Vortioxetine
Cognitive dysfunction
IGF-1
BDNF
Functioning
Lead sponsor: State Institution, Zaporizhzhia Medical Academy of Post-Graduate Education Ministry of Health of Ukraine
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline to week 8 in Sheehan Disability Scale
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Change from baseline to week 8 in MADRS
timeFrame: Baseline to Week 8
measure: Change from baseline to week 8 in PHQ-9
timeFrame: Baseline to Week 8
measure: Change from baseline to week 8 in CGI-S
timeFrame: Baseline to Week 8
measure: Change from baseline to week 8 in PDQ-5-D
timeFrame: Baseline to Week 8
measure: Change from baseline to week 8 in RAVLT
timeFrame: Baseline to Week 8
measure: Change from baseline to week 8 in TMT-B
timeFrame: Baseline to Week 8
measure: Change from baseline to week 8 in DSST
timeFrame: Baseline to Week 8
measure: Change from baseline to week 8 in plasma levels of IGF-1
timeFrame: Baseline to Week 8
measure: Change from baseline to week 8 in plasma levels of BDNF
timeFrame: Baseline to Week 8
measure: Change from baseline to week 8 in plasma levels of CRP
timeFrame: Baseline to Week 8
measure: Change from baseline to week 8 in plasma levels of cortisol
timeFrame: Baseline to Week 8
measure: Change from baseline to week 8 in plasma levels of ACTH
timeFrame: Baseline to Week 8
Other outcomes:
Locations:
city: Zaporizhzhia
country: Ukraine
facility: State Institution "Zaporizhzhia Medical Academy of Postgraduate Education Ministry of Health of Ukraine"
Study officials:
References:
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.