NCT04884893

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 13, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

May 21, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2021

Completed
Last Updated

December 10, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

March 9, 2021

Last Update Submit

December 9, 2021

Conditions

Nitrous OxideElectroencephalographyAnesthetic, Inhalation

Keywords

EEGSlow wave activityNitrous oxideN-methyl-D-aspartate-receptor blockadeDelta waveSelf-reported psychiatric symptoms

Outcome Measures

Primary Outcomes (2)

  • Slow wave activity

    Delta wave in EEG

    During nitrous oxide administration

  • Slow wave activity

    Delta wave in EEG

    Following 20 minutes after nitrous oxide administration

Secondary Outcomes (11)

  • Self-reported psychiatric symptoms

    Baseline, 20 minutes after nitrous oxide

  • Side effects - anxiety

    Baseline, 20 minutes after nitrous oxide

  • Side effects - restlessness

    Baseline, 20 minutes after nitrous oxide

  • Side effects - mood elevation

    Baseline, 20 minutes after nitrous oxide

  • Side effects - nausea

    Baseline, 20 minutes after nitrous oxide

  • +6 more secondary outcomes

Study Arms (2)

Intermittent nitrous oxide

EXPERIMENTAL

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

Drug: Nitrous Oxide

Continuous nitrous oxide

EXPERIMENTAL

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

Drug: Nitrous Oxide

Interventions

Nitrous OxideDRUG

50% nitrous oxide

Continuous nitrous oxideIntermittent nitrous oxide

Eligibility Criteria

Age18 Years - 40 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsFemales excluded due to higher risk of nausea and due to menstrual cycle's effect on EEG
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • informed consent obtained
  • age between 18 - 40
  • male
  • body mass index 18 - 27

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, 33521, Finland

Location

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Nitrous Oxide

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen OxidesGasesInorganic ChemicalsNitrogen CompoundsOxidesOxygen Compounds

Study Officials

  • Maija-Liisa Kalliomäki, MD, PhD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2021

First Posted

May 13, 2021

Study Start

May 21, 2021

Primary Completion

September 24, 2021

Study Completion

September 24, 2021

Last Updated

December 10, 2021

Record last verified: 2021-03

Locations

FI(1)