EVERAGING INFLAMMATION FOR PRECISION MEDICINE IN DEPRESSIO

Not Applicable

Recruiting

• Conditions: F32; F31; Depressive episode; Bipolar affective disorder

• Registration Number: DRKS00029350
• Lead Sponsor: Goethe Universität Frankfurt

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 530

Inclusion Criteria

Patients with depression:
Age: between 18 and 75 years
Presence of depressive disorder without psychotic symptoms (according to ICD 10: F32.0, F32.1, F32.2, F32.3, F33.2, F33.3) or bipolar affective disorder with depressive episode (ICD: F31.3, F31.4)
Capacity to consent

Patients with MS:
Inclusion criteria for patients* with MS:
o Age between 18 and 75
o Capacity to consent
o If applicable, the last cortisone treatment has taken place at least 7 days ago.
occurred

Controls:Inclusion criteria for healthy controls:
Age: between 18 and 75 years
Capacity to consent

Exclusion Criteria

Exclusion criteria for patients with depression:
Presence of severe neurological disease, such as multiple sclerosis. (adjusted epilepsy is allowed)
Presence of an acute infection (pneumonia, urinary tract infection, sepsis)
Clearly organic or substance-induced cause of depression
Pregnancy and lactation
Psychiatric comorbidities are allowed as long as, in the opinion of the study physician there is no impairment at testing and will be documented
Other medical condition that, at the discretion of the physician, makes participation impossible.
Uncontrolled thyroid disease (thyroid disease must be anamnestically stable, i.e., no change in medication has been made in the last 28 days).

Exclusion criteria for patients with MS:
Acute infection (per history) or tumor.
Uncontrolled thyroid disease (thyroid disease must be anamnestically stable, i.e., no change in medication has been made in the last 28 days).

Exclusion criteria for healthy controls:
Presence of psychiatric illness or psychiatric illness in First-degree family members
Severe physical illness (tumor disease, chronic/acute infectious disease, neurodegenerative disease, rheumatological disease, severe inflammation, autoimmune diseases, neurological disease)
Pregnancy and lactation
Uncontrolled thyroid disease (thyroid disease must be anamnestically stable, i.e., no change in medication has been made in the last 28 days).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The aim of the study is to establish symptom profiles based on biological and psychological factors that are variably associated with symptom burden

Secondary Outcome Measures

Name	Time	Method
Assessing stress reactivity in depression; Assessing the effect of short chain fatty acids on immune cell subsets