Sevoflurane for Treatment-Resistant Depression

Study Overview
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Brief Summary
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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.

Official Title
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Subanesthetic Sevoflurane for Treatment-Resistant Depression: A Proof-of-Concept Trial

Conditions
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Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major

Intervention / Treatment
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* Drug: Sevoflurane
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sevoflurane<br>Those with 1-hour inhalation of 1% sevoflurane/30% oxygen | Drug: Sevoflurane<br>* Patients receive 1% sevoflurane and 30% oxygen for 1 hour.<br>* Other names: Treatment;Drug: Placebo<br>* Patients received 30% oxygen for 1 hour.<br>* Other names: Control;|
| Placebo Comparator: placebo<br>Those with 1-hour inhalation of 30% oxygen | Drug: Placebo<br>* Patients received 30% oxygen for 1 hour.<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of treatment responses in 17-item Hamilton Depression Rating Scale (HDRS-17) | ≥50% HDRS-17 reduction in depressive symptoms | 24 hours after the end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of treatment responses in HDRS-17 | ≥50% HDRS-17 reduction in depressive symptoms | 2 hours, 7 days,14 days and 28 days after the end of treatment | 
| Rates of remissions in HDRS-17 | HDRS-17 ≤7 points | 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 | 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment | 
| Rates of remissions in MADRS | MADRS <10 | 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) | 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) | 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment | 
| The assessment of anxiety with self-rating scale | The changes of score in Generalized Anxiety Disorder Screener (GAD-7) | 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) | 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) | 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) | 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 | up to 2 hours after the end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment-resistant depression (TRD), major depressive disorder (MDD), sevoflurane