auto - immune diseases mood disorders
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Meets DSM-V criteria for MDD or BD established by MINI Plus - Depression severity > 13 on the HDRS-17 - Age within the range of 18-65 years - Already using an antidepressant and/or mood stabilizer without sufficient clinical response
Exclusion criteria
Exclusion criteria: - Unable to provide informed consent - Receiving care in the context of involuntary treatment and hospitalization. - Existing or planned pregnancy or lactation - Already participating in a other interventional study - If at inclusion the planned next step of treatment will be ECT. - Cancer or history of cancer in the last 5 years (except skin epidermoid cancer or in-situ cervix cancer). - Current manic or mixed episode of bipolar disorders - Current severe alcohol or other substance use disorder, needing treatment in a specialized setting - Alcohol or other substance dependence in the last year which a patient needed treatment in a specialized setting. - Current or recent (last 4 weeks) severe infectious or inflammatory disease - 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is treatment response to 8 weeks of care as usual. We define treatment response based on the improvement in the HDRS17 across this period with a * 50% decrease in HDRS17 total score indicating full response and a 25-49% decrease in the HDRS17 total score indicating partial response. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study endpoints are: - changes in IDS-SR total sum score after 8 weeks. - changes in BSS total sum score after 8 weeks. - changes in BAI total sum score after 8 weeks. | — |
Countries
Netherlands
Outcome results
None listed