Nitrous Oxide for Major Depressive Disorder

• Status: Completed
• Trial end date: 2021-03-31
• Target enrollment: 0
• Participant gender: All

Summary

This study aims at investigating the persistence of antidepressant effect of Nitrous Oxide (N2O) for Treatment-Resistant Depression(TRD). The investigators also aim to assess the effect of N2O on the electroencephalograph, multimodal magnetic resonance imaging(MRI), blood cytokines, feces bacteria flora and neuropsychological performance in patients with TRD. The investigators further aim to identify the predictors of N2O's antidepressant effeect using the above techniques.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lingjiang Li
• Treatments: Nitrous Oxide

Criteria

Inclusion Criteria:

• Adult (≥18 years, both sexes), with ICD-10 criteria for MDD without psychosis, as determined by a structured clinical interview Mini International Neuropsychiatric Interview

• Moderate to severe depression, as defined by a pretreatment score >17 on the HDRS-17 scale

• TRD was defined as having had at least two adequate dose-duration, antidepressant medication failures in the current episode and a lifetime failure of at least three antidepressant medication trials.

• Informed consent to participate in this study

Exclusion Criteria:

• A history of bipolar disorder, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, panic disorder, or documented Axis II diagnoses; active suicidal intention, as determined by clinical interview

• Active or recent (<12 months) substance abuse or dependence; excluding nicotine

• Presence of acute medical illness that could interfere with study participation, including significant pulmonary disease

• Acute severe suicidal ideation

• Acute psychosis

• Received ECT treatment within 6 months

• History of NMDA-antagonists (e.g., ketamine) intake

• Pregnancy or breastfeeding

• Any contraindications to the use of nitrous oxide (e.g., pneumothorax, middle ear occlusion, elevated intracranial pressure, chronic cobalamin or folate deficiency unless treated with folic acid or vitamin B12).