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PET imaging of neuroinflammation in treatment resistant major depressive disorder

PET imaging of neuroinflammation in treatment resistant major depressive disorder - TRD-inflammation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON38861
Enrollment
60
Registered
2013-09-11
Start date
2014-06-25
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Depression Treatment Refractory Depression Treatment Resistant Depression

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 (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

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 (

Design outcomes

Primary

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

Secondary

MeasureTime frame
Secondary study parameters are serum proteins indicative of inflammation, the inflammation signature of monocytes, levels of poly unsaturated fatty-acids, salivary cortisol measurements and the MRI measures.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)