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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03932825
Recruitment Status Recruiting
First Posted May 1, 2019
Last update posted September 18, 2020
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.
|Experimental: Nitrous oxide
Participants in this group inhale mixed 50% nitrous oxide and 50% oxygen.
Drug: Nitrous Oxide
An 1-hour session of inhaled nitrous oxide at concentrations of 50%.
|Placebo Comparator: Air oxygen mixture
participants in this arm inhale mixed oxygen-air gas (inspired oxygen concentration ~50%).
An 1-hour session of mixed oxygen-air gas(inspired oxygen concentration ~50%)
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- Adult (≥18 years, both sexes), with ICD-10 criteria for MDD without psychosis, as
determined by a structured clinical interview Mini International Neuropsychiatric
- Moderate to severe depression, as defined by a pretreatment score >17 on the HDRS-17
- 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
- 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).
Contact: lingjiang li, MD 0086-13807314575 LLJ2920@csu.edu.cn
Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University
Principal Investigator: Lingjiang Li, MD Mental Health Institute, the Second Xiangya Hospital of Central South University