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

March 27, 2023 updated by: Medical University of Bialystok

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.

Study Overview

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).

Study Type

Observational

Enrollment (Actual)

120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  • 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
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:

  • 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
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:

  • 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
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:

  • 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
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:

  • 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
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:

  • 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
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:

  • 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
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:

  • 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
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:

  • 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 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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

October 31, 2019

Study Completion (Actual)

October 31, 2019

Study Registration Dates

First Submitted

January 24, 2023

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

April 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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