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Coping with psychosocial stress situations in patients with depressive disorder

Coping with psychosocial stress situations in patients with depressive disorder in relation to age and unravelling the mechanisms involved

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN12025504
Enrollment
240
Registered
2025-09-04
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biological stress, inflammation markers and psychocial stress in depressive disorder Mental and Behavioural Disorders

Interventions

The research will include patients diagnosed with an acute depressive episode and healthy volunteers of the same age without a history of mental disorder and severe physical illness. The cohort will c
2. Group of participants with a history of depressive disorder not experiencing empathic pain (group D0)
3. Group of healthy volunteers with a negative psychiatric history experiencing empathic pain (KS group)
4. Group of healthy volunteers with a negative psychiatric history and no history of experiencing empathic pain (K0 group) Healthy volunteers will be matched by age, sex, and BMI to the patients. T

Sponsors

Grant Agency of Ministry of Education, science, research and sport of the Slovak Republic and the Slovak Academy of Science
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Adults (18-55 years) and adolescents (15-18 years) 2. BMI 18.5-26.5 kg/m² 3. History of depressive disorder with or without empathic pain 4. Healthy volunteers with a negative psychiatric history with or without empathic pain

Exclusion criteria

Exclusion criteria: 1. Severe somatic disease 2. Endocrinopathy 3. Organic CNS damage 4. No substance abuse

Design outcomes

Primary

MeasureTime frame
1. Depressive symptoms severity is measured using The Beck Depression Inventory (BDI) at a single time point. 2. The Amount of stress of individuals experiences is assessed using by Holmes-Rahe Stress Inventori (HRSI) at a single time point. 3. The capacity of individuals empathy is measured using The Basic Empathy Scale (BSE) at a single time point.

Secondary

MeasureTime frame
1. Activation of sympathetic nervous system and hypothalamus-hypophysis-adrenal gland axis is measured by socially evaluated cold pressor test at a single time point. 2. Cognitive performance is evaluated by Stroop test (also a social stress stimulus) at a single-time point. 3. Aldosterone levels in saliva will be determined using an own modified method (Hlavacova et al. 2013) at specified times pre-, during and after exposure of stress stimulus. 4. Cortisol in saliva and in hair sample is measured by ELISA using commercial kit at specified times pre-, during and after exposure of stress stimulus. 5. Alpha-amylase in saliva is measured by ELISA using commercial kit at specified times pre-, during and after exposure of stress stimulus. 6. IL-1ß in saliva is measured by ELISA using commercial kit at specified times pre-, during and after exposure of stress stimulus. 7. Blood preassure and heart-frequency and its variability is measured by certified chest belt pre- during and post stress exsposure. 8. Anxiety-like behaviour in female rats is assessed using The Elevated Plus Maze Test (EPM test) at a single time point. 9. Depression-like behaviour in female rats is assessed using The Sucrose Preference Test (Hlavacova et al. 2012) at a single time point. 10. Cognitive performance in female rats is assessed using The Novel Object Recognition Test (Hlavacova et al. 2015) at a single-time point. 11. The novel object recognition test is used as a working memory task to assess cognitive performance as described previously (Hlavacova et al. 2015) at a single-time point. 12. 5-bromo-2-deoxyuridine (BrdU) as a marker of cell proliferation and neurogenesis in female rats are measured by ELISA using commercial kit in selected brain structures, particularly in the hippocampus at a single time point 13. Changes on molecural level in female rats are investigated at the protein level by Western blot analysis and at gene expression level using RT-PCR and real-time PCR at a sin

Countries

Slovakia

Contacts

Public ContactLubomíra ;Daniela Izáková;Ježová

;

lubomira.izakova@gmail.com;daniela.jezova@savba.sk+4212 572 90 339;+421 02/ 32295 215

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026