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Suicidal BehaviourNCT05803447

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

An observational study of Suicidal Behaviour and Cognitive Functions Confusion, run by Medical University of Bialystok.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 20 to 50 years
What is being tested?
Interview questionnaire, biochemical parameters and cognitive function
How many people
120 participants
Where
No sites listed yet
Study dates
1 Sep 2016to 31 Oct 2019
Phase
Observational
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 20 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

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.

Who may be able to join

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

Who cannot join

  • 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

About this study

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

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.

Read the detailed 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).

Being tested
Interview questionnaire, biochemical parameters, cognitive function
Keywords
depression, schizophrenia, biochemical blood tests, oxidative stress pathway
Medical subject headings
Confusion, Depression, Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interview questionnaireOther

    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.

  • 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

  • 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).

Study groups in NCT05803447
Study groupRoleWhat they receive
G1K-womenThe 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)
Receives: Other: Interview questionnaire; Diagnostic Test: biochemical parameters; Diagnostic Test: cognitive function
G1M-menThe 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)
Receives: Other: Interview questionnaire; Diagnostic Test: biochemical parameters; Diagnostic Test: cognitive function
G2K-womenThe 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)
Receives: Other: Interview questionnaire; Diagnostic Test: biochemical parameters; Diagnostic Test: cognitive function
G2M-menThe 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)
Receives: Other: Interview questionnaire; Diagnostic Test: biochemical parameters; Diagnostic Test: cognitive function
G3K-womenThe 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)
Receives: Other: Interview questionnaire; Diagnostic Test: biochemical parameters; Diagnostic Test: cognitive function
G3M-menThe 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)
Receives: Other: Interview questionnaire; Diagnostic Test: biochemical parameters; Diagnostic Test: cognitive function
G0K-womenThe 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)
Receives: Other: Interview questionnaire; Diagnostic Test: biochemical parameters; Diagnostic Test: cognitive function
G0M-menThe 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)
Receives: Other: Interview questionnaire; Diagnostic Test: biochemical parameters; Diagnostic Test: cognitive function

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: in the first 48 hours after the hospital admission

Secondary outcomes (4)

  1. 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).

    Measured: 1 week

  2. 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).

    Measured: 1 week

  3. 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.

    Measured: 1 week

  4. 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.

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2023
  2. Study start1 Sep 2016
  3. Primary completion31 Oct 2019
  4. Study completion31 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Prospective
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05803447
Sponsor's protocol ID
N/ST/ZB/17/003/3316
Status last verified
Mar 2023
First submitted
24 Jan 2023
Last updated
7 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 29587888

  • 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.

    PubMed 25308058

  • 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.

    PubMed 24459374

  • 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.

    PubMed 28508107

  • 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.

    PubMed 33126414

  • 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.

    PubMed 31420027

  • 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.

    PubMed 32162978

  • 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.

    PubMed 32949038

  • 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.

    PubMed 34780105

  • 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.

    PubMed 29542039

  • 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.

    PubMed 26445247

  • 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.

    PubMed 28931301

  • 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.

    PubMed 25636585

Questions about this trial

What is this clinical trial studying?

An observational study of Suicidal Behaviour and Cognitive Functions Confusion, run by Medical University of Bialystok.

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 4 inclusion and 4 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: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). 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 NCT05803447, which also lists 13 linked publications.

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 7 Apr 2023.

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