Severe depressive episode without psychotic symptoms
Conditions
Interventions
Study intervention (12 participants): inhalation of 50% concentration of nitrous oxide diluted in 50% oxygen for 60 minutes twice a week, four weeks in a row.
Control intervention (11 participants):
Drug
E02.319
Sponsors
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
O Instituto Nacional de Ciência e Tecnologia Translacional em Medicina
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients with major depressive episode according to the DSM-5 criteria, aged between 18 and 65 years, on antidepressant treatment without dose adjustment for more than 4 weeks, and who scored > 17 on 17-item-Hamilton Depression Rating Scale.
Exclusion criteria
Exclusion criteria: Presence of relevant clinical conditions (cardiovascular diseases, severe arterial hypertension, renal insufficiency, liver disease, hypothyroidism, chronic obstructive pulmonary disease, B12 hypovitaminosis, epilepsy, pregnancy and breastfeeding); patients with relevant psychiatric comorbidities, especially substance use disorders (except caffeine and nicotine), clinical history of hypomania or mania episode induced by antidepressant medication; patients with clinical criteria of inpatient treatment; nasal septum and difficulty in breathing through the nose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in depressive symptoms. Score reduction in 17 item-Hamilton Depression Rating Scale after treatment termination compared to initial score. . | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in depressive symptoms. Score reduction in Beck Depression Inventory after treatment termination compared to initial score. ;Appearance of mania symptoms during each treatment session. Scoring greater than 12 on the Young Mania Rating Scale.;Improvement in suicidal ideation or the emergence of suicidal ideation or suicide behavior during treatment. Changes in Columbia- Suicide Severity Rating Scale during treatment.;Therapeutic response rate of depressive episode after treatment. Reduction of 50% or more from the initial score on the Hamilton Depression Rating Scale of 17 items after treatment termination.;Remission rate of depressive episode after treatment. Score equal or less than 13 in the Beck Depression Inventory after the end of treatment.;Therapeutic response rate of depressive episode after treatment. Reduction of 50% or more from the initial Beck Depression Inventory score after treatment termination.;Remission rate of depressive episode after treatment. Score equal or less than 13 in the Hamilton Depression Rating Scale of 17 items after the end of treatment.;Adverse effects reported by the subjects and those observed by the researcher in each treatment session. | — |
Countries
Brazil
Contacts
Public ContactMara Guimarães
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Outcome results
None listed