Effects of Nitrous Oxide augmentation of the drug treatment of Depressive Disorder

Phase 1

• Conditions: Severe depressive episode without psychotic symptoms; Moderate depressive episode.; F32.2; F32.1

• Registration Number: RBR-5rz5ch
• Lead Sponsor: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-04
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in depressive symptoms.<br>Score reduction in 17 item-Hamilton Depression Rating Scale after treatment termination compared to initial score. .