Depression
Conditions
Interventions
Low-Intensity aIH Group.:One day intermittent hypoxia intervention and one day normoxic pseudo intervention were alternated for a total of 10 days, with a cumulative interval of 5 days for intermitten
High-Intensity aIH Group.:Continuous intermittent hypoxia intervention for 10 days, with a cumulative hypoxia time of 40 minutes per participant in a single trial, totaling 400 minutes throughout the
Sham Stimulation Group.:Under the same cyclic arrangement as the intervention group, a 64 minute normobaric oxygen intervention (FiO2=21%) was conducted for 1 day, followed by a 10 day intervention wi
Sponsors
Beijing Anding Hospital, affiliated with Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) Outpatient or inpatient patients aged 18 to 45 (including 18 and 45 years old), regardless of gender; (2) The current episode meets the diagnostic criteria for primary or recurrent major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and is not accompanied by psychotic symptoms; (3) Montgomery Depression Rating Scale (MADRS) score = 22 at screening and baseline; (4) This episode was not treated with systemic medication or the medication regimen and dosage were stable for at least 2 weeks; (5) Those who have not been above an altitude of 1500 meters in the past 30 days; (6) Primary school education or above, able to understand the content of the scale; (7) The patient personally signs the informed consent form.
Exclusion criteria
Exclusion criteria: (1) According to DSM-5 criteria, current or previous diagnoses include neurodevelopmental disorders, neurocognitive disorders, bipolar disorder, schizophrenia spectrum and other psychiatric disorders, substance related and addictive disorders; (2) The total score of the Scale for Suicide Ideation (SSI) is greater than 6; (3) Accompanied by significant psychotic symptoms (delusions, hallucinations); (4) Suffering from nervous system diseases, such as epilepsy, cerebrovascular diseases, intracranial infectious diseases or demyelinating diseases, brain edema, and other serious neurosis; (5) History of chest tightness and pain; (6) Subjects with cardiovascular diseases such as hypertension, arrhythmia, coronary heart disease, mitral stenosis and atrial fibrillation, myocardial infarction, heart wall thrombosis or valve vegetations, congestive heart failure, endocarditis, etc; (7) Subjects with respiratory diseases such as sleep apnea, asthma, chronic obstructive pulmonary disease, and pulmonary edema; (8) Severe liver and kidney dysfunction, malignant tumors, or serious diseases that require internal medicine intervention or surgical intervention; (9) Severe thyroid dysfunction; (10) Subjects with obvious abnormal bleeding function or severe hematological disorders; (11) Subjects who currently require treatment such as oxygen therapy to improve their body's oxygenation level; (12) Participants in other clinical trials within the past 3 months; (13) Pregnant and lactating women, as well as patients who are unable to use appropriate contraceptive measures during the trial period; (14)The researchers believe that the subjects are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduced score of Montgomery Depression Rating Scale compared to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment response rate(MADRS<12 points);Effective rate of treatment (MADRS total score reduction rate from baseline = 50%);Hamilton Depression Scale - Changes in 17 items compared to baseline;Changes in Clinical General Impression Scale from Baseline;Changes in depression symptom records (self-assessment) compared to baseline;Changes in the SDS from Baseline;SF12- Changes in Quality of Life Questionnaire from Baseline;Changes in digital breadth test compared to baseline;Changes in digital symbol conversion test compared to baseline;Changes in individual hypoxia tolerance;Changes in Depression Perception Deficiency Questionnaire Compared to Baseline;Physical examination;vital signs;ECG;adverse event;Blood routine;blood biochemical;blood clotting;urinalysis;Thyroid Function;Changes in nuclear magnetic resonance compared to baseline;Changes in neurophysiology compared to baseline; | — |
Countries
China
Contacts
Public ContactWang Gang
Beijing Anding Hospital, affiliated with Capital Medical University
Outcome results
None listed