MOODSTRATIFICATION Immune Signatures for Therapy Stratification in Major Mood Disorders

Withdrawn

• Conditions: 10003816; 10002252; 10027946; auto - immune diseases; mood disorders

• Registration Number: NL-OMON48608
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 90

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

- 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)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is treatment response to 8 weeks of care as usual. We<br /><br>define treatment response based on the improvement in the HDRS17 across this<br /><br>period with a * 50% decrease in HDRS17 total score indicating full response<br /><br>and a 25-49% decrease in the HDRS17 total score indicating partial response.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study endpoints are:<br /><br>- changes in IDS-SR total sum score after 8 weeks.<br /><br>- changes in BSS total sum score after 8 weeks.<br /><br>- changes in BAI total sum score after 8 weeks.</p><br>