This study intends to carry out a prospective, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subanesthetic sevoflurane for treatment-resistant depression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
15
Patients receive 1% sevoflurane and 30% oxygen for 1 hour.
Patients received 30% oxygen for 1 hour.
Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, China
Rates of treatment responses in 17-item Hamilton Depression Rating Scale (HDRS-17)
≥50% HDRS-17 reduction in depressive symptoms
Time frame: 24 hours after the end of treatment
Rates of treatment responses in HDRS-17
≥50% HDRS-17 reduction in depressive symptoms
Time frame: 2 hours, 7 days,14 days and 28 days after the end of treatment
Rates of remissions in HDRS-17
HDRS-17 ≤7 points
Time frame: 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment
Rates of treatment responses in Montgomery-Åsberg Depression Rating Scale (MADRS)
≥50% MADRS reduction in the baseline score
Time frame: 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment
Rates of remissions in MADRS
MADRS \<10
Time frame: 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment
The assessment of depression with self-rating scale
The changes of score in Patient Health Questionnaire-9 (PHQ-9)
Time frame: 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment
The assessment of anxiety by psychiatrist
The changes of score in Hamilton Anxiety Rating Scale (HAMA)
Time frame: 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment
The assessment of anxiety with self-rating scale
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The changes of score in Generalized Anxiety Disorder Screener (GAD-7)
Time frame: 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment
The assessment of improvement by psychiatrist
The changes of score in Clinical Global Impression (CGI)
Time frame: 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment
The assessment of improvement with self-rating scale
The changes of score in Patient Global Impressions of Improvement (PGI-I)
Time frame: 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment
The assessment of side effects with self-rating scale
Including Patient Rated Inventory of Side Effects (PRISE)
Time frame: 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment
Side effects of sevoflurane
Including nausea, vomiting, headache, dizzy, hypotension, hypoxemia, carbon dioxide accumulation, et al
Time frame: up to 2 hours after the end of treatment