SleepLess - Imaging synaptic plasticity in therapeutic sleep deprivation for major depressio

Not Applicable

Recruiting

• Conditions: acute sleep deprivationhealthy subjects; F32.2; F33.2; Severe depressive episode without psychotic symptoms; Recurrent depressive disorder, current episode severe without psychotic symptoms

• Registration Number: DRKS00027867
• Lead Sponsor: Forschungszentrum Jülich GmbH, Institut für Neurowissenschaften und Medizin (INM-2)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Age between 20 and 50
- Male or female
- Presentation of a written declaration of consent
- For women of childbearing age: a negative pregnancy test, and use of effective contraception for at least 3 months.
- Depressive disorder (ICD-10: F32.2 and F33.2)
- Score of =15 on the 21-item Hamilton Rating Scale for Depression (HAMD).

Exclusion Criteria

- BMI > 35
- Lack of a legally valid declaration of consent
- Not able to speak German
- Any medication with influence on the examination parameters
- Blood-thinning medication or known (diagnosed) coagulation disorders
- Chronic diseases: e.g. neurological, cardiopulmonary, endocrinological, renal, hepatic, psychiatric (except depressive disorder), autoimmunological diseases
- DSM-V Axis I disorder (lifetime) other than depressive disorder, such as schizophrenia, schizoaffective disorder, other non-bipolar mental disorders, bipolar disorder, primary anxiety disorder or obsessive-compulsive disorder, mental retardation, signs of impaired cognitive performance
- psychotic symptoms, suicidal intentions
- sleep disturbances in healthy subjects
- Shift and night work
- Occupational exposure to radiation
- Drug dependence
- Electrical implants for stimulation or therapy
- All metallic objects on or in the body (e.g. surgical screws, implants and/or osteosynthesis
and/or osteosynthesis material) for which there is no MRI compatibility
- Fixed braces or retainer wires
- Tattoos in the examined body region
- Intensive grinding work on metallic objects in the past month
- Complaints, e.g. back pain, which make it difficult to lie still for a longer period of time.
- Pregnancy, breastfeeding women
- Incapacitated persons, persons with limited legal capacity and persons in official or judicial custody.
- Any other condition which, in the opinion of the doctors conducting the study, makes the subject unsuitable (e.g. claustrophobia, non-compliance).
- Copper IUDs
- Hormonal IUDs with interaction in relation to MRI
- Excessive caffeine intake (regularly >500 mg caffeine or five cups of coffee per day).
- Excessive smoking (>15 cigarettes/day)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is hypothesised that sleep deprivation in healthy subjects will result in an increase in synaptic density (SV2A-PET) in the prefrontal cortex compared to a baseline condition without sleep deprivation and a test-retest control group without sleep deprivation.<br>It is hypothesised that in subjects with a depressive disorder, synaptic density in the prefrontal cortex is lower than in the control group.<br>It is hypothesised that sleep deprivation will lead to mood improvement in a proportion of subjects with depressive disorder and that synaptic density in the prefrontal cortex will increase in these responders (compared to the baseline condition without sleep deprivation).<br>It is hypothesised that an increase in synaptic density is associated with an increase in cortical excitability (TMS).

Secondary Outcome Measures

Name	Time	Method
It is assumed that an increase in synaptic density after sleep deprivation can also be observed in other brain regions.