PET imaging of neuroinflammation in treatment resistant major depressive disorder

Completed

• Conditions: Chronic Depression; Treatment Refractory Depression; Treatment Resistant Depression; 10027946

• Registration Number: NL-OMON38861
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Patients
- Age above 18 and below 50 years
- Written informed consent for participation
- Diagnosis of MDD as ascertained by structured Clinical Interview for DSM-IV (SCID-I) or MiniScan.
- HDRS-17 >20
- High level of treatment resistance/refractoriness (Ruhe et al. 2012) as defined by non-response (<50% decrease in symptoms) after >3 classes of antidepressants, given for at least 4 weeks at at least minimal effective dosages. The last antidepressant may be continued during the study.;Healthy controls
- Age above 18 and below 50 years
- Written informed consent for participation

Exclusion Criteria

Patients
- The use of benzodiazepines within 1 week prior to the PET-scan (benzodiazepines with half-lives >24hrs must be stopped >5 times this half live before the PET-scan).
- The use of anticoagulants or having coagulation disorder.
- Use of somatic medication that may affect the immune system (e.g. corticoids, anti-inflammatory drugs, immune suppressive drugs)
- Use of any investigational drug
- Current or recent (<1 year) alcohol or substance abuse
- Current or recent (<4 weeks) infectious or inflammatory disease
- Current systemic disease
- Somatic, organic or neurological disorder
- Claustrophobia
- Presence of materials in the body that can be magnetized, like a pacemaker, metal fragments, shunts, artificial heart valves, vascular clips, fixed hearing aid, tattoos containing metal, hair implants and artificial dentures.;Healty controls
Identical to patients plus:
- Personal history of (lifetime) psychiatric disorders
- Major metabolic disease (diabetes, hyper- or hypothyroidism, Cushing disease or Addison disease)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is the [11C]-PK11195 binding potential in the brain. We expect<br /><br>increased binding potential in hippocampus, other parts of the limbic system<br /><br>(e.g. amygdala, insula) and regions involved in emotion-regulation (e.g.<br /><br>anterior cingulate cortex (ACC), ventromedial and dorsolateral prefrontal<br /><br>cortex (VM/DL PFC). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are serum proteins indicative of inflammation, the<br /><br>inflammation signature of monocytes, levels of poly unsaturated fatty-acids,<br /><br>salivary cortisol measurements and the MRI measures. </p><br>