Synaptic mechanisms of therapeutic sleep deprivation in major depressio

Not Applicable

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

• Registration Number: DRKS00008014
• Lead Sponsor: niversitätsklinikum FreiburgKlinik für Psychiatrie und Psychotherapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Ages = 18 = 65
• Ability to provide informed consent
• normal or corrected-to-normal vision
• Absence of any exclusion criteria
• Major depressive disorder (ICD-10: F32.2 and F33.2)
• Score of =15 on the 21-item Hamilton Rating Scale for Depression (HAMD)

Exclusion Criteria

• Neurological disorders including epilepsy, history of brain injury, encephalitis, or any organic brain syndrome
• metallic implants
• present pregnancy
• DSM-V axis I disorder (lifetime) apart from major depression, such as schizophrenia, schizoaffective disorder, any non-bipolar psychotic disorder, bipolar disorders, primary anxiety or obsessive compulsive disorder, mental retardation, signs of impaired cognitive functioning
• Lifetime history for drug/alcohol dependence, or drug/alcohol abuse within the past year
• Medication with any anxiolytic or antipsychotic drug, except antidepressants for patients
• Medical conditions including severe cardiac, liver, kidney, endocrine (e.g., diabetes), hematologic disorders (e.g., porphyria or any bleeding abnormalities), other impairing or unstable medical condition or impending surgery
• Primary sleep disorders diagnosed according to DSM-V criteria.
• Inability to read or understand the study forms and agree to informed consent.
• Irregular sleep schedules associated with shift work, frequent travel, or personal preference as indicated by weekly variation of >3 hours in bed time or wake time, or sleep duration <5.5 or > 10 hours per night.
• Left-handedness
• Acute suicidality
• Psychotic features of MDD
• Excessive use of caffeine (>300 mg or three cups of coffee per day).
• Excessive smoking (>10 cigarettes/day).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
increase of the mean motor evoked potential (MEP) amplitude 30 min after paired associative stimulation (PAS) compared to baseline in the morning after one night of sleep deprivation

Secondary Outcome Measures

Name	Time	Method
EEG theta power of the wake-EEG, mean reaction time in the Psychomotor Vigilance Task (PVT), recall performance in a declarative memory task (word-pair associates), BDNF genotype, BDNF serum level and salivary cortisol levels, transcranial magnetic stimulation (TMS) responses in non-responders to sleep deprivation. All examinations will take place in the morning after one night of therapeutic sleep deprivation.