Nitrous Oxide for Major Depressive Disorder

NCT ID: NCT03932825

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2021-03-31

Brief 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Air oxygen mixture

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

An 1-hour session of mixed oxygen-air gas(inspired oxygen concentration \~50%)

Nitrous oxide

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

Group Type: EXPERIMENTAL

Nitrous Oxide

Intervention Type: DRUG

An 1-hour session of inhaled nitrous oxide at concentrations of 50%.

Interventions

Nitrous Oxide

An 1-hour session of inhaled nitrous oxide at concentrations of 50%.

Intervention Type: DRUG

Placebo

An 1-hour session of mixed oxygen-air gas(inspired oxygen concentration \~50%)

Intervention Type: DRUG

Other Intervention Names

Laughing Gas; Xiao Qi; 笑气; Air oxygen mixture

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lingjiang Li

OTHER

Sponsor Role: lead

Responsible Party

Lingjiang Li

President of Chinese Psychiatry Society of Chinese Medical Association

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lingjiang Li, MD

Role: PRINCIPAL_INVESTIGATOR

Mental Health Institute, the Second Xiangya Hospital of Central South University

Locations

Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University

Changsha, Hunan, China

Countries

China

Other Identifiers

18-05-04-XY-0001

Identifier Type: -

Identifier Source: org_study_id