Clinical trial NCT04884893: Effect of Nitrous Oxide on EEG
Official title: The Effect of Nitrous Oxide on EEG, a Randomized, Double-blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nitrous Oxide
Electroencephalography
Anesthetic, Inhalation
Keywords: EEG
Slow wave activity
Nitrous oxide
N-methyl-D-aspartate-receptor blockade
Delta wave
Self-reported psychiatric symptoms
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University
name: University of Helsinki
First posted: 2021-05-13
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Our recent preclinical observations suggest that monitoring of slow electroencephalogram (EEG) oscillations may be used to predict the efficacy of rapid-acting antidepressants such as ketamine or nitrous oxide. In this project we will carry out critical clinical research on healthy volunteers and study the effects of nitrous oxide on EEG. Results will be used for the design of clinical trials on depressed individuals. The project will be done in collaboration between neuroscientists at the University of Helsinki and clinicians at the Tampere University Hospital.


Eligibility criteria: Inclusion Criteria:

1. informed consent obtained
2. age between 18 - 40
3. male
4. body mass index 18 - 27

Exclusion Criteria:

1. Age \< 18 or \> 40
2. Alcohol Use Disorders Identification Test (AUDIT) \>6 points
3. Drug Abuse Screening Test 20 (DAST-20) \> 0 points
4. Beck Depression Inventory (BDI) \> 11 points
5. Symptom Check List 90 (SCL-90) over mean values of Finnish population in any dimensions of the SCL-90 or the global severity index
6. Any respiratory disorder including sleep apnea
7. Any heart illness
8. Epilepsy
9. Known vitamin B12 deficiency

Primary outcomes:
measure: Slow wave activity
timeFrame: During nitrous oxide administration
measure: Slow wave activity
timeFrame: Following 20 minutes after nitrous oxide administration
Secondary outcomes:
measure: Self-reported psychiatric symptoms
timeFrame: Baseline, 20 minutes after nitrous oxide
measure: Side effects - anxiety
timeFrame: Baseline, 20 minutes after nitrous oxide
measure: Side effects - restlessness
timeFrame: Baseline, 20 minutes after nitrous oxide
measure: Side effects - mood elevation
timeFrame: Baseline, 20 minutes after nitrous oxide
measure: Side effects - nausea
timeFrame: Baseline, 20 minutes after nitrous oxide
measure: Side effects - tension
timeFrame: Baseline, 20 minutes after nitrous oxide
measure: Side effects - uneasiness
timeFrame: Baseline, 20 minutes after nitrous oxide
measure: Side effects - tiredness
timeFrame: Baseline, 20 minutes after nitrous oxide
measure: Side effects - numbness
timeFrame: Baseline, 20 minutes after nitrous oxide
measure: Side effects - dizziness
timeFrame: Baseline, 20 minutes after nitrous oxide
measure: Side effects - agitation
timeFrame: Baseline, 20 minutes after nitrous oxide
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Maija-Liisa Kalliomäki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: