NCT05803447

Brief Summary

The aim of this study was to analyse the level of cognitive functioning of patients with history of suicidal behaviour suffering from depression and schizophrenia, and to evaluate their oxidative stress parameters and selected biochemical parameters on the basis of bloodwork.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
Last Updated

April 7, 2023

Status Verified

March 1, 2023

Enrollment Period

3.2 years

First QC Date

January 24, 2023

Last Update Submit

March 27, 2023

Conditions

Keywords

depressionschizophreniabiochemical blood testsoxidative stress pathway

Outcome Measures

Primary Outcomes (1)

  • At the first stage, the participants were interviewed by the certified clinical psychologist. M.I.N.I. 7.0.2 interview was conducted with each patient to verify the intensification of suicidal behaviour.

    The setting of the study assumed that the procedure started in the first 48 h after the hospital admission. Based on the scores M.I.N.I.7.0.2 the patients were classified into one of eight groups: * control groups displaying no suicidal behaviour (G0K - women and G0M - men), the result of M.I.N.I. 7.0.2 test was zero points; * groups experiencing suicidal thoughts without a tendency of implementation (G1K - women and G1M - men), the result of M.I.N.I. 7.0.2 test was 1 to 8 points; * groups experiencing suicidal thoughts with a tendency of implementation (G2K - women and G2M - men), the result of M.I.N.I. 7.0.2 test was 9 to 16 points; * groups after a suicide attempt (G3K - women and G3M - men), the result of M.I.N.I. 7.0.2 test was equal to or greater than 17 points.

    in the first 48 hours after the hospital admission

Secondary Outcomes (4)

  • The second stage of the study consisted of biochemical blood tests - vitamins

    1 week

  • The second stage of the study consisted of biochemical blood tests - ions

    1 week

  • The second stage of the study consisted of biochemical blood tests - total cholesterol, LDL, HDL, TG

    1 week

  • The second stage of the study consisted of biochemical blood tests - oxidative stress

    1 week

Other Outcomes (2)

  • The third stage of the study consisted of the participants completing a Cogstate (full name of the test) computerized test to verify their cognitive functioning. Part 1.

    between 20 to 45 minutes

  • The third stage of the study consisted of the participants completing a Cogstate (full name of the test) computerized test to verify their cognitive functioning. Part 2.

    between 20 to 45 minutes

Study Arms (8)

G1K-women

The G1K group consisted of women experiencing suicidal thoughts without a tendency of implementation, in whom the result of M.I.N.I. 7.0.2 test was 1 to 8 points (n=14)

Other: Interview questionnaireDiagnostic Test: biochemical parametersDiagnostic Test: cognitive function

G1M-men

The G1M group consisted of men experiencing suicidal thoughts without a tendency of implementation, in whom the result of M.I.N.I. 7.0.2 test was 1 to 8 points (n=16)

Other: Interview questionnaireDiagnostic Test: biochemical parametersDiagnostic Test: cognitive function

G2K-women

The G2K group consisted of women experiencing suicidal thoughts with a tendency of implementation, in whom the result of M.I.N.I. 7.0.2 test was 9 to 16 points (n=19)

Other: Interview questionnaireDiagnostic Test: biochemical parametersDiagnostic Test: cognitive function

G2M-men

The G2M group consisted of men experiencing suicidal thoughts with a tendency of implementation, in whom the result of M.I.N.I. 7.0.2 test was 9 to 16 points (n=9)

Other: Interview questionnaireDiagnostic Test: biochemical parametersDiagnostic Test: cognitive function

G3K-women

The G3K group consisted of women after a suicide attempt, in whom the result of M.I.N.I. 7.0.2 test was equal to or greater than 17 points (n=15)

Other: Interview questionnaireDiagnostic Test: biochemical parametersDiagnostic Test: cognitive function

G3M-men

The G3M group consisted of men after a suicide attempt, in whom the result of M.I.N.I. 7.0.2 test was equal to or greater than 17 points (n=17)

Other: Interview questionnaireDiagnostic Test: biochemical parametersDiagnostic Test: cognitive function

G0K-women

The G0K group consisted of women displaying no suicidal behaviour, in whom the result of M.I.N.I. 7.0.2 test was zero points (n=10)

Other: Interview questionnaireDiagnostic Test: biochemical parametersDiagnostic Test: cognitive function

G0M-men

The G0M group consisted of men displaying no suicidal behaviour, in whom the result of M.I.N.I. 7.0.2 test was zero points (n=20)

Other: Interview questionnaireDiagnostic Test: biochemical parametersDiagnostic Test: cognitive function

Interventions

An Interview questionnaire concerning an assessment of the intensity suicidal behavior, M.I.N.I. 7.0.2 was used. M.I.N.I. interview was conducted with each patient to verify the intensification of suicidal behaviour.

G0K-womenG0M-menG1K-womenG1M-menG2K-womenG2M-menG3K-womenG3M-men
biochemical parametersDIAGNOSTIC_TEST

The concentrations of the following parameters were determined from the: * blood serum: vitamin D3, B12, folic acid, sodium, potassium, calcium, magnesium, chlorine, total cholesterol, LDL and HDL fractions, TG * plasma: metabolites of the oxidative stress

G0K-womenG0M-menG1K-womenG1M-menG2K-womenG2M-menG3K-womenG3M-men
cognitive functionDIAGNOSTIC_TEST

The participants completing cognitive function were assessed using computer CogState Test. The following cognitive functions were assessed: psychomotor drive (DET), metastability of attention (IDN), verbal memory, retrieval of learned material (ISLR) and verbal learning and memory (ISL), visual learning and memory (OCL), processing speed (GMCT), visual memory including deferred retrieval (GMR), executive functions (SETS and GML), working memory (ONB, TWOB).

G0K-womenG0M-menG1K-womenG1M-menG2K-womenG2M-menG3K-womenG3M-men

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The research included 120 people (58 women and 62 men) who met the criteria for being incluted in the study and who did not possess exclusion criteria.

You may qualify if:

  • patients of clinical psychiatry
  • patients diagnosed with schizophrenia and depression
  • age: 20-50 years
  • gender: women and men

You may not qualify if:

  • use of psychoactive substances
  • decreased level of cognitive functioning
  • people who do not use a computer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • Ribeiro JD, Huang X, Fox KR, Franklin JC. Depression and hopelessness as risk factors for suicide ideation, attempts and death: meta-analysis of longitudinal studies. Br J Psychiatry. 2018 May;212(5):279-286. doi: 10.1192/bjp.2018.27. Epub 2018 Mar 28.

  • Dalglish SL, Melchior M, Younes N, Surkan PJ. Work characteristics and suicidal ideation in young adults in France. Soc Psychiatry Psychiatr Epidemiol. 2015 Apr;50(4):613-20. doi: 10.1007/s00127-014-0969-y. Epub 2014 Oct 12.

  • Talreja BT, Shah S, Kataria L. Cognitive function in schizophrenia and its association with socio-demographics factors. Ind Psychiatry J. 2013 Jan;22(1):47-53. doi: 10.4103/0972-6748.123619.

  • Kishi T, Matsuda Y, Iwata N. Memantine add-on to antipsychotic treatment for residual negative and cognitive symptoms of schizophrenia: a meta-analysis. Psychopharmacology (Berl). 2017 Jul;234(14):2113-2125. doi: 10.1007/s00213-017-4616-7. Epub 2017 May 15.

  • Koweszko T, Gierus J, Zalewska A, Maciejczyk M, Waszkiewicz N, Szulc A. The Relationship between Suicide and Oxidative Stress in a Group of Psychiatric Inpatients. J Clin Med. 2020 Oct 28;9(11):3462. doi: 10.3390/jcm9113462.

  • Roca M, Del Amo AR, Riera-Serra P, Perez-Ara MA, Castro A, Roman Juan J, Garcia-Toro M, Garcia-Pazo P, Gili M. Suicidal risk and executive functions in major depressive disorder: a study protocol. BMC Psychiatry. 2019 Aug 16;19(1):253. doi: 10.1186/s12888-019-2233-1.

  • Liaugaudaite V, Fineberg NA, Podlipskyte A, Gecaite J, Juskiene A, Mickuviene N, Burkauskas J. Neurocognitive markers of suicidal ideation in patients with anxiety and mood disorders. Int J Psychiatry Clin Pract. 2020 Jun;24(2):116-119. doi: 10.1080/13651501.2019.1666148. Epub 2020 Mar 12.

  • Yin Y, Tong J, Huang J, Tian B, Chen S, Cui Y, An H, Tan S, Wang Z, Yang F, Tian L, Tong Y, Hong LE, Tan Y. Suicidal ideation, suicide attempts, and neurocognitive dysfunctions among patients with first-episode schizophrenia. Suicide Life Threat Behav. 2020 Dec;50(6):1181-1188. doi: 10.1111/sltb.12689. Epub 2020 Sep 19.

  • Wang J, Tang X, Lu Y, Zheng Y, Zeng F, Shi W, Zhou P. Lycopene Regulates Dietary Dityrosine-Induced Mitochondrial-Lipid Homeostasis by Increasing Mitochondrial Complex Activity. Mol Nutr Food Res. 2022 Jan;66(1):e2100724. doi: 10.1002/mnfr.202100724. Epub 2021 Nov 28.

  • Moraes JB, Maes M, Roomruangwong C, Bonifacio KL, Barbosa DS, Vargas HO, Anderson G, Kubera M, Carvalho AF, Nunes SOV. In major affective disorders, early life trauma predict increased nitro-oxidative stress, lipid peroxidation and protein oxidation and recurrence of major affective disorders, suicidal behaviors and a lowered quality of life. Metab Brain Dis. 2018 Aug;33(4):1081-1096. doi: 10.1007/s11011-018-0209-3. Epub 2018 Mar 14.

  • Liu T, Zhong S, Liao X, Chen J, He T, Lai S, Jia Y. A Meta-Analysis of Oxidative Stress Markers in Depression. PLoS One. 2015 Oct 7;10(10):e0138904. doi: 10.1371/journal.pone.0138904. eCollection 2015.

  • Vergallo A, Giampietri L, Baldacci F, Volpi L, Chico L, Pagni C, Giorgi FS, Ceravolo R, Tognoni G, Siciliano G, Bonuccelli U. Oxidative Stress Assessment in Alzheimer's Disease: A Clinic Setting Study. Am J Alzheimers Dis Other Demen. 2018 Feb;33(1):35-41. doi: 10.1177/1533317517728352. Epub 2017 Sep 21.

  • Lang E, Lang F. Mechanisms and pathophysiological significance of eryptosis, the suicidal erythrocyte death. Semin Cell Dev Biol. 2015 Mar;39:35-42. doi: 10.1016/j.semcdb.2015.01.009. Epub 2015 Jan 28.

MeSH Terms

Conditions

ConfusionDepressionSchizophrenia

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2023

First Posted

April 7, 2023

Study Start

September 1, 2016

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

April 7, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share