MOODSTRATIFICATION IMMUNOSTRATA Groningen Premature immune ageing to predict the effect of physical training intervention in mood disorders
- Conditions
- mood disordersbipolar disorder & major depressive disorder10027946
- Registration Number
- NL-OMON54984
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 125
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
- Preferably already on an anti-depressant and/or mood stabilizer apparently
without success
- Signed informed consent, able to understand, speak and write the national
language
- Use of beta blockers or other medication affecting hearth frequency
- Abnormalities on ECG (other than normal sinus rhythm)
- 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
Healthy controls:
- 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)
- 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).
- Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>High and low senescent CD8 T cells (either determined by CD28 negativity or<br /><br>CD57 positivity), i.e. higher or lower than the mean of the senescent CD8+ T<br /><br>cells in the total depression group at base-line. Response to treatment will be<br /><br>analysed via HDRS-17 score improvement and responders and non-responders will<br /><br>be defined via the 50% improvement in HDRS-17 score</p><br>
- Secondary Outcome Measures
Name Time Method <p>Other immune senescence markers<br /><br>1. High and low number of *senescent* CD4+ T cells in the effector<br /><br>memory (EM) and effector memory re-expressing CD45RA (EMRA) populations<br /><br>2. High and low signs of monocyte senescence: Monocyte gene expression<br /><br>of mitochondrial apoptosis (BAX, BCL10, EGR1, EGR2) and the SASP related gene<br /><br>TNF<br /><br>3. High and low signs of the monocyte inflammatory pyroptosis state:<br /><br>Monocyte gene expression of the inflammatory genes IL-1A, IL-1B, IL-6, CCL20<br /><br>and TNFAIP3<br /><br>4. Correlates of high and low signs of the monocyte senescent and<br /><br>inflammatory state in whole blood material TEMPUS): The gene expression of<br /><br>amongst others BAX, SERPINE1, TGFBR3, NFATC2, TNFAIP3, FOXP3 and CD8<br /><br>5. High or low levels of the T cell senescence related growth serum<br /><br>factor IL-7<br /><br>6. High or low levels of the inflammaging serum factors hsCRP and IL-6</p><br>