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The role of cognitive and emotional risk factors in decision-making

Recruiting
Conditions
Adjustment disorders
F31.3
F31.4
Bipolar affective disorder, current episode severe depression without psychotic symptoms
F32
Depressive episode
Bipolar affective disorder, current episode mild or moderate depression
F33
F43.2
Recurrent depressive disorder
Registration Number
DRKS00015610
Lead Sponsor
niversitätsklinikum der RWTH Aachen
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
60
Inclusion Criteria

General inclusion criteria:
- Subject is 18 to 60 years of age on the day of signing informed consent.
- Subject agrees to participate by providing written informed consent
- Subject is able to obtain full insight into the objectives of the clinical trial and is fully contractually capable as assessed by an independent psychiatrist.
- For patients: voluntary treatment in the Department for Psychiatry, Psychotherapy and Psychosomatics.
Special inclusion criteria:
Group 1
- Suicidal behavior (suicide ideas, realized or interrupted suicide attempts) within the last 6 months
- Subject meets ICD-10 criteria for single depressive episode (F32.x), bipolar depression (F31.x), recurrent depression (F33.x) or adjustment disorder with depressive reaction (F43.2).
- Absence of acute suicidality and stabile psychopathological state.
- Persistence of depressive symptoms (BDI = 14).
Group 2
- Lifetime absence of suicidal behavior (suicide ideas, realized or interrupted suicide attempts)
- Subject meets ICD-10 criteria for single depressive episode (F32.x), bipolar depression (F31.x), recurrent depression (F33.x) or adjustment disorder with depressive reaction (F43.2).
- Absence of acute suicidality and stabile psychopathological state.
- Persistence of depressive symptoms (BDI = 14).
Group 3
- Healthy volunteers without a history of mental diseases or suicidality

Exclusion Criteria

- Any comorbidity including following diagnostic categories: Organic, including symptomatic, mental disorders (F00-F09), Schizophrenia, schizotypal and delusional disorders (F20-F29), Mental retardation (F70-F79), Disorders of psychological development (F80-89).
- Subject has an unstable, severe medical disorder.
- Subject is hospitalized or treated coercively by order of the responsible local authorities.
- Subject (in the investigator's and - if necessary - an independent psychiatrist’s judgment) poses a serious suicidal or homicidal risk at the screening visit
- Subject has a clinically significant abnormality in the neurological assessments at screen or base
- subject is in a dependent position toward the investigators.

Study & Design

Study Type
observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The current study aims to test previously suicidal, depressed patients compared to depressed patients without suicidality and healthy controls with regard to following primary outcome parameters:<br>Decision-making task (DOSE): loss aversion und risk aversion <br>Emotional stroop task (EST): Interference effect<br>Stop-Signal-Response-Task (SSRT): Inhibition effect <br>Childhood Trauma Questionnaire (CTQ): summarized score and subscores for physical, mental and sexual traumatic experience <br>
Secondary Outcome Measures
NameTimeMethod
The secondary outcome parameters will be assessed using the following questionnaires and examinations:<br>-Becks Depressions Inventory-II (BDI-II; Self rating) und Hamilton Depression Scale (HAMD) (external rating)<br>-Suicide Severity Rating Scale (C-SSRS), German Capability for Suicide Questionnaire (GCSQ), Interpersonal Needs Questionnaire (INQ) (assessment of suicidality) <br>-Beck Hopelessness Scale (assessment of hopelessness)<br>-Temperament and Character Inventory (TCI) (assessment of personality attributes)<br>- Trail Making Task – TMT(A) und TMT(B) (cognitive flexibility)<br>- Barratt Impulsiveness Scale (BIS-11) (Impulsiveness)<br>-Cognitive Fusion Questionnaire (CFQ-D) und Metacognitions Questionnaire (MCQ) (ability of cognitive fusion)<br>-Laboratory parameters: Testosterone, Estrogen, Progesterone, Brain-derived neurotrophic factor (BDNF), Cortisol.<br>- Elektrodermal Activity (EDA) <br>
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