Acute Intermittent Hypoxia Therapy for Depression
Reason given: The study was withdrawn before enrollment of the first participant due to changes in the research plan.
Trial details
- Who runs it
- Capital Medical University
- Trial code
- NCT07921654
- Record updated
- 10 November 2026
- Original description
The goal of this clinical trial is to evaluate the efficacy of acute intermittent hypoxia for the treatment of patients with major depressive disorder. The study will also assess the safety and tolerability of acute intermittent hypoxia and explore its potential mechanisms underlying its antidepressant effects.Read full original descriptionShow less
Efficacy and Safety of Acute Intermittent Hypoxia Therapy for Major Depressive Disorder: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate the efficacy of acute intermittent hypoxia for the treatment of patients with major depressive disorder. The study will also assess the safety and tolerability of acute intermittent hypoxia and explore its potential mechanisms underlying its antidepressant effects.
Inclusion: Outpatients or inpatients aged 18 to 45 years, inclusive, of any sex; Current episode meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for first-episode or recurrent major depressive disorder, without psychotic features during the current episode; Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥22 at both screening and baseline; No current use of antidepressants, antipsychotics, or mood stabilizers. Participants with prior use must have completed an adequate washout period before enrollment: at least 5 drug half-lives, or at least 28 days for fluoxetine; Long-term residence in a low-altitude plain area and no travel to areas above 1,500 meters in altitude within the past 30 days; Education level above primary school and ability to understand the contents of the study scales; Written informed consent provided by the participant.
Exclusion: Current or previous diagnosis, according to DSM-5 criteria, of neurodevelopmental disorders, neurocognitive disorders, bipolar disorder, schizophrenia spectrum and other psychotic disorders, or substance-related and addictive disorders; Current need for oxygen therapy or other treatment to improve systemic oxygenation; Subjects who have received neuromodulation treatment, MECT, or systematic psychotherapy within the past 3 months; Presence of neurological diseases, such as epilepsy, cerebrovascular disease, intracranial infectious disease, demyelinating disease, cerebral edema, or other severe neurological disorders; History of chest tightness or chest pain; Severe cardiovascular disease, such as severe hypertension, arrhythmia, coronary heart disease, mitral stenosis, atrial fibrillation, myocardial infarction, intracardiac mural thrombus or valvular vegetation, congestive heart failure, or endocarditis; Respiratory disease, such as sleep apnea, asthma, chronic obstructive pulmonary disease, or pulmonary edema; Severe hepatic or renal insufficiency, malignant tumor, or other severe disease requiring medical intervention or surgery; Significant coagulation abnormalities or severe hematologic disease; Any condition that, in the investigator's judgment, makes the participant unsuitable for this study; Score ≥4 on item 10 of the MADRS suicide item; Severe thyroid dysfunction; Participation in another clinical trial within the past 3 months; Pregnant or breastfeeding women, or participants who are unable to use appropriate contraception during the study.