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This study evaluated the effects of Nitrous Oxide on major depressive disorder (including treatment-resistant depression), compared with placebo. Adults aged 18 and older with moderate-to-severe depression who had not responded adequately to previous treatments were eligible. The study was carried out in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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).