Chronic Depression Treatment Refractory Depression Treatment Resistant Depression
Conditions
Interventions
None listed
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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