Effect of Nitrous Oxide on EEG

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-21

Study Completion Date

2021-09-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Nitrous Oxide Electroencephalography Anesthetic, Inhalation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intermittent nitrous oxide

10 minutes of 50% nitrous oxide + 10 min 100% oxygen + 10 min 50% nitrous oxide + 10 min 100% oxygen

Group Type EXPERIMENTAL

Nitrous Oxide

Intervention Type DRUG

50% nitrous oxide

Continuous nitrous oxide

20 min 50% nitrous oxide + 20 min 100% oxygen

Group Type EXPERIMENTAL

Nitrous Oxide

Intervention Type DRUG

50% nitrous oxide

Interventions

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Nitrous Oxide

50% nitrous oxide

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes