Prediction and Validation of Unipolar Depression With Psychosocial-somatic Markers in a Naturalistic Cohort Recruited in an Outpatient Setting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

950 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-15

Study Completion Date

2032-10-15

Brief Summary

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The POKAL-PSY project is a study that monitors participants for five years. The goal of the study is to identify distinguishable subtypes of depression on the basis of biomarkers and to gain insight into their prognostic significance.

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Detailed Description

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Conditions

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Depressive Disorder Depression Depressive Symptoms Depressive Episode Major Depressive Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

At inclusion mentally healthy and patients with a depression are monitored for five years. After study inclusion participants will be seen after four weeks and then annually for five years.

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Patients with depression

Group Type ACTIVE_COMPARATOR

drawing blood

Intervention Type DIAGNOSTIC_TEST

drawing blood annually measurement of heartrate variability annually determine weight with a bioimpedance scale

Healthy controls

Group Type ACTIVE_COMPARATOR

drawing blood

Intervention Type DIAGNOSTIC_TEST

drawing blood annually measurement of heartrate variability annually determine weight with a bioimpedance scale

Interventions

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drawing blood

drawing blood annually measurement of heartrate variability annually determine weight with a bioimpedance scale

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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bioimpedance scale measurement of heartrate variability

Eligibility Criteria

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Inclusion Criteria

* (PHQ\>8) if depressed
* Subjects of any sex aged between 18-70
* Sufficient ability to speak and understand the german language
* Ability to understand and sign the informed consent form

Exclusion Criteria

* Cognitive impairment that interferes with reliable completion of questionnaires or answering questions
* Presence of manic episode, bipolar disorder, Schizophrenia or schizoaffective disorder (as well as other diseases in the F2 domain in the ICD), active eating disorder, active drug or alcohol dependence syndrome
* Presence of uncontrolled systemic disease (e.g. autoimmune disease), uncontrolles somatic (other than metabolic or cardiovascular)/ neurologic diseases, current or recent (last month) physical trauma
* Patient with acute suicidal ideation
* known deficiency of alpha-1-antitrypsin
* pregnant or lactating women

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes