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

Shanghai First Maternity and Infant Hospital1 site in 1 country15 target enrollmentAugust 2021

ConditionsDepressive Disorder, Treatment-Resistant Depressive Disorder, Major

InterventionsSevoflurane Placebo

DrugsSevoflurane Placebo

Overview

Phase: Not Applicable
Intervention: Sevoflurane
Conditions: Depressive Disorder, Treatment-Resistant
Sponsor: Shanghai First Maternity and Infant Hospital
Enrollment: 15
Locations: 1
Primary Endpoint: Rates of treatment responses in 17-item Hamilton Depression Rating Scale (HDRS-17)
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2021

End Date

March 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai First Maternity and Infant Hospital

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

sevoflurane

Those with 1-hour inhalation of 1% sevoflurane/30% oxygen

Intervention: Sevoflurane

sevoflurane

Those with 1-hour inhalation of 1% sevoflurane/30% oxygen

Intervention: Placebo

placebo

Those with 1-hour inhalation of 30% oxygen

Intervention: Placebo

Outcomes

Primary Outcomes

Rates of treatment responses in 17-item Hamilton Depression Rating Scale (HDRS-17)

Time Frame: 24 hours after the end of treatment

≥50% HDRS-17 reduction in depressive symptoms

Secondary Outcomes

Rates of remissions in HDRS-17(2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment)
Rates of remissions in MADRS(2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment)
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 assessment of improvement with self-rating scale(2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment)
Rates of treatment responses in HDRS-17(2 hours, 7 days,14 days and 28 days after the end of treatment)
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 assessment of improvement by psychiatrist(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(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)(2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment)
The assessment of anxiety by psychiatrist(2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment)
Side effects of sevoflurane(up to 2 hours after the end of treatment)