MOODSTRATIFICATION IMMUNOSTRATA Groningen Premature immune ageing and spinning therapy in mood disorders

Recruiting

• Conditions: mood disorders; bipolar disorder & major depressive disorder; 10027946

• Registration Number: NL-OMON52015
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 132

Inclusion Criteria

Patients
- A depressive episode in the course of unipolar or bipolar disorder with a
HDRS-17 score >13 - Meets DSM criteria for MDD or BD established by MINI
interview.
- Age 18-65 years
- Already on an anti-depressant and/or mood stabilizer apparently without
success - Signed informed consent, able to understand, speak and write the
national language

Healthy ontrols
- No history of psychiatric disorders
- Age 18-65 years
- Signed informed consent, able to understand, speak and write the national
language

Exclusion Criteria

- Use of beta blockers or other medication affecting hearth frequency (patients)
- Abnormalities on ECG (other than normal sinus rhythm) (patients)
- Chronic use of anti-inflammatory drugs
- Existing cancer or history of cancer in the last 5 years (except skin
epidermoid cancer or in-situ cervix cancer)
- Existing or planned pregnancy or lactation
- Schizoaffective disorders, schizophrenia
- Immediate risk for suicidal behavior (3 on HamD-17 rating scale
- Known current uncontrolled systemic disease (e.g. LE, RA).
- Known major uncontrolled metabolic disorder (e.g. diabetes, hyper- or
hypothyroidism, Cushing disease of Addison disease).
- Known other significant uncontrolled somatic/organic/neurological disorder,
such as or diabetes or stroke which may affect mood.
- Current or recent (last 4 weeks) use of somatic medication which may affect
mood or the immune system (e.g. corticoids, anti-inflammatory drugs, immune
suppressive drugs).
- Participation in a study of an investigational drug or device concomitantly
or within 30 days prior to this study
- Patients thought to be unreliable or incapable of complying with the
requirements of the protocol
- Patient is relative of, or staff directly reporting to the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Senescent CD8 T cells (either determined by CD28 negativity or CD57 positivity)<br /><br>as modifying factor<br /><br>Response to treatment will be analysed via HDRS-17 score improvement.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Other immune senescence markers<br /><br>1. Number of *senescent* CD4+ T cells in the effector memory (EM) and effector<br /><br>memory re-expressing CD45RA (EMRA) populations<br /><br>2. Signs of monocyte senescence: Monocyte gene expression of mitochondrial<br /><br>apoptosis (BAX, BCL10, EGR1, EGR2) and the SASP related gene TNF<br /><br>3. Signs of the monocyte inflammatory pyroptosis state: Monocyte gene<br /><br>expression of the inflammatory genes IL- 1A, IL-1B, IL-6, CCL20 and TNFAIP3<br /><br>4. Correlates of the monocyte senescent and inflammatory state in whole blood<br /><br>material TEMPUS): The gene expression of amongst others BAX, SERPINE1, TGFBR3,<br /><br>NFATC2, TNFAIP3, FOXP3 and CD8<br /><br>5. Levels of the T cell senescence related growth serum factor IL-7 6. High or<br /><br>low levels of the inflammaging serum factors hsCRP and IL-6</p><br>