Analysis of Parameters Indicating the Intensity of Suicidal Behavior in Psychiatric Patients

Suicidal Behaviour Clinical Trial

Official title:

Analysis of Parameters Indicating the Intensity of Suicidal Behavior in Patients Suffering From Depression and Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05803447
• Other study ID #: N/ST/ZB/17/003/3316
• Status: Completed
• Start date: September 1, 2016
• Est. completion date: October 31, 2019

Study information

• Verified date: March 2023
• Source: Medical University of Bialystok
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The study was conducted among 120 patients hospitalized in the Department of Psychiatry of the UMB (Medical University of Białystok). Every participant gave their own voluntary and informed written consent. Blood parameters tests were performed in the Diagnostic Laboratory of the University's Clinical Hospital and in the Department of Hygiene, Epidemiology and Ergonomics of the Medical University of Białystok. In the first stage of the study, an M.I.N.I. 7.0.2 interview was conducted with each patient to verify the intensification of suicidal behaviour. Based on the scores, the patients were classified into one of eight groups: no suicidal behaviour group (G0K, G0M); group experiencing suicidal thoughts without a tendency of implementation (G1K, G1M); group experiencing suicidal thoughts with a tendency of implementation (G2K, G2M); group after a suicide attempt (G3K, G3M).The second stage of the study consisted of biochemical blood tests, where concentrations of vitamin D3, B12, folic acid, sodium, potassium, calcium, magnesium, chlorine, total cholesterol, LDL and HDL fractions, TG and metabolites of the oxidative stress pathway were determined. The following concentrations were determined: dityrosine (AUF/mg protein), TOS (nmol H2O2 Equiv/mg protein), TAC (umol/mg protein), OSI (TOS/TAC ratio), FRAP (μmol/mg protein), GPx (mU/mg protein), SOD (mU/mg protein) CAT (nmol H2O2/min/mg protein), AOPP (nmol/mg protein), NO (nmol/mg protein), GSH (μg/mg protein). The third stage of the study consisted of the participants completing a CogState computerized test to verify their cognitive functioning. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• patients of clinical psychiatry

• patients diagnosed with schizophrenia and depression

• age: 20-50 years

• gender: women and men

Exclusion Criteria:

• exclusion criteria were any present major medical illness (somatic or neurological disease)

• use of psychoactive substances

• decreased level of cognitive functioning

• people who do not use a computer

Related Conditions & MeSH terms

• Cognitive Functions Confusion
• Confusion
• Suicidal Behaviour

Intervention

Other:
• Interview questionnaire
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.

Diagnostic Test:
• biochemical parameters
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
• cognitive function
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Bialystok

References & Publications (13)

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. — View Citation

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 1 — View Citation

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. — View Citation

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. — View Citation

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: 10.1080/13651 — View Citation

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. — View Citation

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 r — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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 — View Citation

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 — View Citation

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. 20 — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	The test was performed independently, after obtaining instructions for each task given by a psychologist. The duration of the test ranged from 20 to 45 minutes.	between 20 to 45 minutes
Other	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.	Parameters were evaluated using unit: lmn - speed of execution (log10 milliseconds) acc - accurancy (the square root of the proportion of correct answers) ter - number of errors mps - number of movements per second cor - number of correct answers err - number of errors	between 20 to 45 minutes
Primary	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	The second stage of the study consisted of biochemical blood tests - vitamins	Venous blood (10 mL) was collected from all patients, then were left at room temperature for 30-60 minutes to separate the serum. After that the blood was centrifuged at 4500 x g for 20 min at 4 °C. In the next phase, some of the test tubes used to determine the concentration of vitamins (vitamin D3, B12, folic acid) were immediately used to perform these determinations standard method used in the hospital laboratory USK in Bialystok. The laboratory used Abbott equipment to perform these determinations (Architect 25-OH Vitamin D, Architect i System, Architect Follate).	1 week
Secondary	The second stage of the study consisted of biochemical blood tests - ions	Venous blood (10 mL) was collected from all patients, then were left at room temperature for 30-60 minutes to separate the serum. After that the blood was centrifuged at 4500 x g for 20 min at 4 °C. In the next phase, some of the test tubes used to determine the concentration of ions (calcium, magnesium, chlorine, sodium, potassium) were immediately used to perform these determinations standard method used in the hospital laboratory USK in Bialystok. The laboratory used Abbott Alnity c equipment to perform these determinations. The remaining tubes were placed in a freezer at -17 to -12°C, and after 24 hours the samples were stored at the temperature of -80° C in which they were stored until being assayed (total cholesterol, LDL, HDL, TG).	1 week
Secondary	The second stage of the study consisted of biochemical blood tests - total cholesterol, LDL, HDL, TG	Venous blood (10 mL) was collected from all patients, then were left at room temperature for 30-60 minutes to separate the serum. After that the blood was centrifuged at 4500 x g for 20 min at 4 °C. The remaining tubes were placed in a freezer at -17 to -12°C, and after 24 hours the samples were stored at the temperature of -80° C in which they were stored until being assayed (total cholesterol, LDL, HDL, TG). Total cholesterol and serum HDL cholesterol remained determined by the enzymatic-colorimetric method. The LDL cholesterol level was calculated from the formula Friedewald.	1 week
Secondary	The second stage of the study consisted of biochemical blood tests - oxidative stress	The another laboratory tests were performer to determine parameters of oxidative stress.; The following concentrations were determined: dityrosine (AUF/mg protein), TOS (nmol H2O2 Equiv/mg protein), TAC (umol/mg protein), OSI (TOS/TAC ratio), FRAP (µmol/mg protein), GPx (mU/mg protein), SOD (mU/mg protein) CAT (nmol H2O2/min/mg protein), AOPP (nmol/mg protein), NO (nmol/mg protein), GSH (µg/mg protein).; The obtained plasma was precooled in liquid nitrogen and stored at -80°C. Tests were made using a Sigma-Aldrich device, using 96 well microplate reader (InfiniteM200 PROMultimode Tecan; Tecan Group Ltd) absorbance/fluorescence of the plates was measured. The results were standardized to 1 mg proteins and the measurements were performed on two samples to verify the results.	1 week