Sevoflurane for Treatment-Resistant Depression
- Conditions
- Depressive Disorder, MajorDepressive Disorder, Treatment-Resistant
- Interventions
- Drug: Placebo
- Registration Number
- NCT05008939
- Lead Sponsor
- Shanghai First Maternity and Infant Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 15
- age 18-65 years
- meeting DSM-V criteria for major depressive disorder
- a pretreatment score ≥17 on HDRS-17
- meeting criteria for TRD, defined as having had at least two adequate dose-duration antidepressant medication failures in the current depressive episode.
- current treatment drugs were stably used for at least 4 weeks
- MDD with psychosis, e.g., bipolar disorder, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, panic disorder, et al
- Drug, tobacco or alcohol abuse
- active suicidal intention
- previous administration of NMDA receptor antagonists (e.g., ketamine)
- previous (<6 weeks prior) or ongoing treatment with electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS)
- pregnancy or breastfeeding
- morbidly obese, BMI>35kg/m2
- other diseases that could interfere with the results
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo Placebo Those with 1-hour inhalation of 30% oxygen sevoflurane Placebo Those with 1-hour inhalation of 1% sevoflurane/30% oxygen sevoflurane Sevoflurane Those with 1-hour inhalation of 1% sevoflurane/30% oxygen
- Primary Outcome Measures
Name Time Method Rates of treatment responses in 17-item Hamilton Depression Rating Scale (HDRS-17) 24 hours after the end of treatment ≥50% HDRS-17 reduction in depressive symptoms
- Secondary Outcome Measures
Name Time Method Rates of remissions in HDRS-17 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment HDRS-17 ≤7 points
Rates of remissions in MADRS 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment MADRS \<10
The assessment of anxiety with self-rating scale 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment The changes of score in Generalized Anxiety Disorder Screener (GAD-7)
The assessment of improvement with self-rating scale 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment The changes of score in Patient Global Impressions of Improvement (PGI-I)
The assessment of depression with self-rating scale 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment The changes of score in Patient Health Questionnaire-9 (PHQ-9)
Rates of treatment responses in HDRS-17 2 hours, 7 days,14 days and 28 days after the end of treatment ≥50% HDRS-17 reduction in depressive symptoms
The assessment of improvement by psychiatrist 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment The changes of score in Clinical Global Impression (CGI)
The assessment of side effects with self-rating scale 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment Including Patient Rated Inventory of Side Effects (PRISE)
Rates of treatment responses in Montgomery-Åsberg Depression Rating Scale (MADRS) 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment ≥50% MADRS reduction in the baseline score
The assessment of anxiety by psychiatrist 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment The changes of score in Hamilton Anxiety Rating Scale (HAMA)
Side effects of sevoflurane up to 2 hours after the end of treatment Including nausea, vomiting, headache, dizzy, hypotension, hypoxemia, carbon dioxide accumulation, et al
Trial Locations
- Locations (1)
Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
🇨🇳Shanghai, Shanghai, China