The Effect of Stress on Neuroendocrine Markers and Functional Connectivity in Children and Adolescents with Depressive and Anxiety Disorders

Not Applicable

Recruiting

• Conditions: F32.1; F32.2; F32.3; F33.1; F33.2; F33.3; F40.0; F40.00; F40.01; F40.1

• Registration Number: DRKS00032507
• Lead Sponsor: Klinik und Poliklinik für Kinder- und Jugendpsychiatrie der Universität Regensburg am Bezirksklinikum Regensburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

General inclusion criteria
- Sufficient understanding of the German language
- Informed consent of the study participants and their legal guardians
- Age at the beginning of the study participation: 12-17 years

Inclusion criteria patient group depressive disorders
- Primary diagnosis of a depressive disorder according to the diagnostic criteria of the DSM-V classification and ICD-10 (Moderate depressive episode (F32.1), Major depressive episode without psychotic symptoms (F32.2), severe depressive episode with psychotic symptoms, Recurrent depressive disorder, current moderate episode (F33.1), Recurrent depressive disorder, current major episode without psychotic symptoms (F33.2), Recurrent depressive disorder, current major episode with psychotic symptoms (F33.3))

Inclusion Criteria Patient Group Depressive disorders with comorbid anxiety disorder.
- Primary diagnosis of depressive disorder according to Inclusion criteria patient group depressive disorders.
- Additional diagnosis of an anxiety disorder according to the diagnostic criteria of the DSM-V classification and ICD-10 (agoraphobia (ICD-10 F40.0) without/with details a panic disorder (F40.00, F40.01), social phobias (F40. 1), panic disorder (F41.0), generalized anxiety disorder (F41.1), emotional disorder with separation anxiety of childhood (F93.0), disorders with social anxiety of childhood (F93.2), generalized anxiety disorder of childhood (F93.80)

Inclusion criteria healthy control group
- No psychiatric and neurological pre-existing conditions
- No presence of a mental disorder requiring treatment
- No current or past outpatient, partial hospitalization, or full hospitalization psychiatric or psychotherapeutic interventions

Exclusion Criteria

General exclusion criteria
- Pre-existing neurological or endocrinological disorders
- Known genetic syndromes
- Past traumatic brain injury
- Use of glucocorticoid-containing medications
- Pregnancy or lactation
- Premature pubertal development (pubertas precox vera) due to hormonal status deviating from the norm (Brämswig & Dübbers, 2009)
- Known intellectual impairment (IQ<80).
- School education: Special school
- Acute suicidal tendency
- Other neurological disorders affecting brain development and physiology
- Lack of consent
- MRI-specific contraindications: metallic foreign objects, tattoos with metal-containing pigments, claustrophobia, pacemakers and defibrillator systems, cochlear implant, implanted insulin pumps, non-removable piercings made of magnetic materials.
- At least one of the following mental disorders (current or past).
o Psychotic disorder
o Autism
o Bipolar disorder
o Anorexia nervosa
o Substance dependence

Exclusion Criteria Patient Group Depressive Disorders
- Categorical diagnosis of anxiety disorder

Exclusion criteria control group
- Pre-existing psychiatric and neurological conditions
- Presence of a mental disorder requiring treatment
- Current or past outpatient, inpatient, or partial inpatient psychiatric or psychotherapeutic interventions
- Use of psychotropic drugs and neuroleptics

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. fMRI<br>- structural connectivity differences between relevant areas before and after stress induction are assessed by resting state scans <br>- during stress induction by the MIST paradigm (control and stress condition) task-based fMRI scans are acquired<br>- Using diffusion-weighted imaging (DTI), structural connectivity differences between relevant brain areas are assessed. <br><br>2. Determination of hormone concentrations (oxytocin and cortisol) by collecting saliva samples at eight different time points <br><br><br>Psychosocial stress will be induced using a modified version of the Montreal Imaging Stress Task (MIST; Dedovic et al., 2005).