F32
Conditions
Interventions
Group 1: 40 patients with a depressive episode according to ICD-10
Visit 1 ("Baseline") - This visit takes up to 5-6 hours.
At the beginning of the study, you will be asked to participate in an initi
Sponsors
Uniklinik Köln, Klinik für Psychiatrie und Psychotheapie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Age equal to or above 18 years • Capacity to provide informed consent • Written informed consent form by the participant • Depressive episode according to ICD-10. The diagnosis will be established by a senior psychiatrist and will be based on clinical examination with the application of the ICD-10 criteria. • Minimal symptoms of motor dysfunction observed on clinical examination and expressed by a Salpetrière Retardation Rating (in depression) Scale (SRRS) score of >1 on the items of motility or slowing of speech.
Exclusion criteria
Exclusion criteria: • Patients with depression according to ICD-10 Principal inclusion criteria: • Age equal to or above 18 years • Capacity to provide informed consent • Written informed consent form by the participant • Depressive episode according to ICD-10. The diagnosis will be established by a senior psychiatrist and will be based on clinical examination with the application of the ICD-10 criteria. • Minimal symptoms of motor dysfunction observed on clinical examination and expressed by a Salpetrière Retardation Rating (in depression) Scale (SRRS) score of >1 on the items of motility or slowing of speech. Principal exclusion criteria: • MRI contraindication: cardiac pacemaker or neurostimulator implantation, metal implants (except teeth), agoraphobia, history of metalworking, injury with shrapnel or metal slivers, and major surgery • Acute suicidality (standardized assessment with the Columbia suicide severity rating scale, C-SSRS) • Bipolar disorder, schizophrenia, dementia • Substance use disorder (current or in the past 5 years) • Neurological diseases (e.g., Parkinson´s disease, multiple sclerosis, history of stroke) • Immune disorder (except Hashimoto-Thyreoditis) • Clinical signs of acute infection • Known dysfunction of the motor system independent of motor retardation related to depression • Constant treatment with antipsychotic medication, intake on the days of examination • Constant treatment with Benzodiazepines, intake on the days of examination • Constant tobacco consumption (>10 cigarettes/day) • Pregnant women and nursing mothers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To measure the neuronal motor control system in patients with depression with at least minimal motor symptoms at baseline and after 5 weeks of follow-up with functional magnetic resonance imaging (fMRI) and to correlate neuronal activation with changes in the motor symptoms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Dimensional Anhedonia Rating Scale (DARS) Montgomery–Åsberg Depression Rating Scale (MADRS) Beck´s Depression Inventory (BDI) Columbia Suicide Severity Rating Scale (C-SSRS) General Motor assessment: covering the three domains (i) basic motor abilities (grip strength, finger tapping frequency), (ii) complex motor abilities, and (iii) cognitive and emotional motor abilities. Actigraphy-based daily activity Quantitative Magnetization Transfer MRI (qMT-MRI) Plasma levels of metabolic parameters (insulin, glucose), inflammatory markers (IL-1ß, IL-6, TNF-a, CRP) | — |
Countries
Germany
Contacts
Public ContactFrank Jessen
Uniklinik Köln, Klinik für Psychiatrie und Psychotherapie
Outcome results
None listed