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| Name | Class |
|---|---|
| Tampere University | OTHER |
| University of Helsinki | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent nitrous oxide | Experimental | 10 minutes of 50% nitrous oxide + 10 min 100% oxygen + 10 min 50% nitrous oxide + 10 min 100% oxygen |
|
| Continuous nitrous oxide | Experimental | 20 min 50% nitrous oxide + 20 min 100% oxygen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitrous Oxide | Drug | 50% nitrous oxide |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported psychiatric symptoms | Symptom Check List 90 (SCL-90) is a self-reported questionnaire measuring psychological stress. Results are normed, meaning that test scores can be compared to Finnish reference values. In this study we measure if there is an increase in self-reported psychiatric symptoms after nitrous oxide administration. | Baseline, 20 minutes after nitrous oxide |
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Inclusion Criteria:
Exclusion Criteria:
Females excluded due to higher risk of nausea and due to menstrual cycle's effect on EEG
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| Name | Affiliation | Role |
|---|---|---|
| Maija-Liisa Kalliomäki, MD, PhD | Tampere University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampere University Hospital | Tampere | 33521 | Finland |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009609 | Nitrous Oxide |
| ID | Term |
|---|---|
| D009589 | Nitrogen Oxides |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
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| Side effects - anxiety | Self reported anxiety on a 0 (no at all) to 5 (very much) scale | Baseline, 20 minutes after nitrous oxide |
| Side effects - restlessness | Self reported restlessness on a 0 (no at all) to 5 (very much) scale | Baseline, 20 minutes after nitrous oxide |
| Side effects - mood elevation | Self reported mood elevation on a 0 (no at all) to 5 (very much) scale | Baseline, 20 minutes after nitrous oxide |
| Side effects - nausea | Self reported nausea on a 0 (no at all) to 5 (very much) scale | Baseline, 20 minutes after nitrous oxide |
| Side effects - tension | Self reported tension on a 0 (no at all) to 5 (very much) scale | Baseline, 20 minutes after nitrous oxide |
| Side effects - uneasiness | Self reported uneasiness on a 0 (no at all) to 5 (very much) scale | Baseline, 20 minutes after nitrous oxide |
| Side effects - tiredness | Self reported tiredness on a 0 (no at all) to 5 (very much) scale | Baseline, 20 minutes after nitrous oxide |
| Side effects - numbness | Self reported numbness on a 0 (no at all) to 5 (very much) scale | Baseline, 20 minutes after nitrous oxide |
| Side effects - dizziness | Self reported dizziness on a 0 (no at all) to 5 (very much) scale | Baseline, 20 minutes after nitrous oxide |
| Side effects - agitation | Self reported agitation on a 0 (no at all) to 5 (very much) scale | Baseline, 20 minutes after nitrous oxide |
| D010087 |
| Oxides |
| D017601 | Oxygen Compounds |