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EUDOR-A Multi-centre Research Program A Naturalistic, European Multi-centre Clinical Study of EDOR Test in adult patients with primary depression

EUDOR-A Multi-centre Research Program A Naturalistic, European Multi-centre Clinical Study of EDOR Test in adult patients with primary depression - EUDOR-A

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00010082
Enrollment
1500
Registered
2016-05-31
Start date
2014-08-05
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Intentional Self-harm F32 F33 F31 F34 F38 F39

Interventions

Group 1: Patients with a primary diagnosis of depression, also in remission, are recruited. Beside demographic information, the following clinical data are obtained: -Primary and secondary psychiatric
-Somatic diagnoses according to ICD-10
-Alcohol and drug abuse
-Pharmacological and psychological treatment
-Actions of intentional self-harm during the last six weeks and lifetime
-Suicide risk assessed according to rules and traditions at the centre. The patients are also assessed through the Montgomery-Asberg Depression Scale. If actions of intentional self-harm occur, the de

Sponsors

Emotra AB
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - In- and outpatients with a primary diagnosis of depression according to the ICD-10, also in remission; - Age: 18 years or older; - Gender: Any; - Signed Informed Consent.

Exclusion criteria

Exclusion criteria: - Patient’s dissent to participate in the study; - In cases of diagnosed or suspected dementia, the patient should to be excluded unless there is a special interest by the centre. If included, this condition must be noted; - In cases of known or suspected alcohol or other substance abuse, the patient has to be excluded unless there is a special interest by the centre. If included, this condition must be noted; - Patient’s inability to understand the instructions for the EDOR Test; - Serious problems of hearing.

Design outcomes

Primary

MeasureTime frame
In the current observational study, the primary variables to be investigated are: - the prevalence of electrodermal hyporeactivity among the depressive patients, recruited and tested in the naturalistic setting of psychiatric clinics; - the incidence of actions of intentional self-harm i.e., suicide after, and suicide attempt before and after test during the one-year follow-up period. It is hypothesized that the EDOR Test will identify electrodermal hyporeactive depressed patients who in turns will show a higher suicidal proneness as indicated by intentional self-harm behaviours. The electrodermal reactivity is assessed through the EDOR Test when the patient is enrolled in the study. The occurrence of intentional self-harm during the one-year follow-up period will be assessed. Information on the method/s used will be obtained and the correspondent ICD-10 code/s will be assigned. The death intent of the worst suicide attempt (according to the patient) will be evaluated using the first eight items of the Beck Suicide Intent Scale.

Secondary

MeasureTime frame
Secondary outcomes to be assessed will be: - the influence of secondary psychiatric diagnoses, antidepressive treatments, somatic diagnoses, as well as demographic characteristics, such as age and gender, on electrodermal reactivity levels; - possible traces of influence on the rate of suicide by the clinical use of the EDOR Test. Information on demographic characteristics, secondary psychiatric diagnoses, antidepressive treatments and somatic diagnoses will be collected immediately after patient’s enrolment. If possible, information on the suicide rates at the participating centres during the last two years before the beginning of the study and during the one-year follow-up period will be gathered. Suicide rates in the centres’ region (at county level or similar) will be also taken in consideration.

Countries

France, Germany, Hungary, Italy, Poland, Portugal, Romania, Spain, Sweden

Contacts

Public ContactMarco Sarchiapone

Department of Medicine and Health Sciences, University of Molise

marco.sarchiapone@unimol.it+39 0874 404728

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 10, 2026