Major Depression as a transient functional lesion model of motor control – longitudinal study

Not Applicable

Recruiting

• Conditions: F32; Depressive episode

• Registration Number: DRKS00030856
• Lead Sponsor: niklinik Köln, Klinik für Psychiatrie und Psychotheapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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

•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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Dimensional Anhedonia Rating Scale (DARS)<br>Montgomery–Åsberg Depression Rating Scale (MADRS)<br>Beck´s Depression Inventory (BDI)<br>Columbia Suicide Severity Rating Scale (C-SSRS)<br>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. <br>Actigraphy-based daily activity<br>Quantitative Magnetization Transfer MRI (qMT-MRI) <br>Plasma levels of metabolic parameters (insulin, glucose), inflammatory markers (IL-1ß, IL-6, TNF-a, CRP) <br>