mood disorders
Conditions
Interventions
Participants in group 1 will receive treatment as usual (TAU), i.e.
pharmacotherapy plus clinical management.
Participants in group 2 will receive TAU combined with exercise training,
consisting o
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| High and low senescent CD8 T cells (either determined by CD28 negativity or CD57 positivity), i.e. higher or lower than the mean of the senescent CD8+ T cells in the total depression group at base-line. Response to treatment will be analysed via HDRS-17 score improvement and responders and non-responders will be defined via the 50% improvement in HDRS-17 score | — |
Secondary
| Measure | Time frame |
|---|---|
| Other immune senescence markers 1. High and low number of *senescent* CD4+ T cells in the effector memory (EM) and effector memory re-expressing CD45RA (EMRA) populations 2. High and low signs of monocyte senescence: Monocyte gene expression of mitochondrial apoptosis (BAX, BCL10, EGR1, EGR2) and the SASP related gene TNF 3. High and low signs of the monocyte inflammatory pyroptosis state: Monocyte gene expression of the inflammatory genes IL-1A, IL-1B, IL-6, CCL20 and TNFAIP3 4. Correlates of high and low signs of the monocyte senescent and inflammatory state in whole blood material TEMPUS): The gene expression of amongst others BAX, SERPINE1, TGFBR3, NFATC2, TNFAIP3, FOXP3 and CD8 5. High or low levels of the T cell senescence related growth serum factor IL-7 6. High or low levels of the inflammaging serum factors hsCRP and IL-6 | — |
Countries
Netherlands
Outcome results
None listed