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The effect of laughing gas on brain elctirc activity and mood

Phase 1
Conditions
DepressionThe main aim of this study is to understand how N2O affects - during gas exposure and upon gas withdrawal - slow EEG oscillations in healthy adult volunteers. The aim is to understand the individual variation to the treatments, the dose-response effects of the treatments and the effect of intermittent dosing of the treatments on EEG.
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Registration Number
EUCTR2018-001818-15-FI
Lead Sponsor
Tampere University Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
Male
Target Recruitment
40
Inclusion Criteria

18-40 years, BMI 18-27
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

no medication/chronic illness, no previous history of psychiatric or substance abuse disorders,

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: The main aim of this study is to understand how N2O affects - during gas exposure and upon gas withdrawal - slow EEG oscillations in healthy adult volunteers. ;Secondary Objective: The impact of the treatments on cognitive functions and psychological state ;Primary end point(s): Slow wave oscillations (EEG)<br>;Timepoint(s) of evaluation of this end point: During administration and directly after administration
Secondary Outcome Measures
NameTimeMethod
Secondary end point(s): Cantab, SCL90 ;Timepoint(s) of evaluation of this end point: Directly after administration
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