- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05803447
Analysis of Parameters Indicating the Intensity of Suicidal Behavior in Psychiatric Patients
Analysis of Parameters Indicating the Intensity of Suicidal Behavior in Patients Suffering From Depression and Schizophrenia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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)
|
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. The concentrations of the following parameters were determined from the:
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).
|
|
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)
|
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. The concentrations of the following parameters were determined from the:
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).
|
|
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)
|
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. The concentrations of the following parameters were determined from the:
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).
|
|
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)
|
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. The concentrations of the following parameters were determined from the:
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).
|
|
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)
|
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. The concentrations of the following parameters were determined from the:
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).
|
|
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)
|
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. The concentrations of the following parameters were determined from the:
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-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)
|
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. The concentrations of the following parameters were determined from the:
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).
|
|
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)
|
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. The concentrations of the following parameters were determined from the:
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
Time Frame: in the first 48 hours after the hospital admission
|
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:
|
in the first 48 hours after the hospital admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The second stage of the study consisted of biochemical blood tests - vitamins
Time Frame: 1 week
|
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
|
|
The second stage of the study consisted of biochemical blood tests - ions
Time Frame: 1 week
|
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
|
|
The second stage of the study consisted of biochemical blood tests - total cholesterol, LDL, HDL, TG
Time Frame: 1 week
|
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
|
|
The second stage of the study consisted of biochemical blood tests - oxidative stress
Time Frame: 1 week
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
Time Frame: between 20 to 45 minutes
|
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
|
|
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.
Time Frame: between 20 to 45 minutes
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N/ST/ZB/17/003/3316
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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