Sevoflurane for Treatment-Resistant Depression

Sponsor

Shanghai First Maternity and Infant Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05008939

Collaborator

Shanghai Pudong New Area Mental Health Center (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder, Treatment-Resistant Depressive Disorder, Major	Drug: Sevoflurane Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: sevoflurane Those with 1-hour inhalation of 1% sevoflurane/30% oxygen	Drug: Sevoflurane Patients receive 1% sevoflurane and 30% oxygen for 1 hour. Other Names: Treatment Drug: Placebo Patients received 30% oxygen for 1 hour. Other Names: Control
Placebo Comparator: placebo Those with 1-hour inhalation of 30% oxygen	Drug: Placebo Patients received 30% oxygen for 1 hour. Other Names: Control

Arm

Intervention/Treatment

Experimental: sevoflurane

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

Drug: Sevoflurane

Patients receive 1% sevoflurane and 30% oxygen for 1 hour.

Other Names:

Treatment

Drug: Placebo

Patients received 30% oxygen for 1 hour.

Other Names:

Control

Placebo Comparator: placebo

Those with 1-hour inhalation of 30% oxygen

Drug: Placebo

Patients received 30% oxygen for 1 hour.

Other Names:

Control

Outcome Measures

Primary Outcome Measures

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

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
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 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
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 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)
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)
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 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 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 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)
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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