Nitrous Oxide for Major Depressive Disorder

Lingjiang Li

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder; Treatment Resistant Depression; Depressive Disorder, Major; Depression; Depressive Disorder

Treatments: Drug: Nitrous Oxide; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03932825

18-05-04-XY-0001

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

44 participants in 2 patient groups, including a placebo group

Air oxygen mixture

Placebo Comparator group

Description:

participants in this arm inhale mixed oxygen-air gas (inspired oxygen concentration \~50%).

Treatment:

Drug: Placebo

Nitrous oxide

Experimental group

Description:

Participants in this group inhale mixed 50% nitrous oxide and 50% oxygen.

Treatment:

Drug: Nitrous Oxide