Sevoflurane for Treatment-Resistant Depression

Shanghai First Maternity and Infant Hospital

Status: Unknown

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

Treatments: Drug: Placebo; Drug: Sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT05008939

ShanghaiFMIH2021 Zhiqiang Liu

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age 18-65 years
2. meeting DSM-V criteria for major depressive disorder
3. a pretreatment score ≥17 on HDRS-17
4. meeting criteria for TRD, defined as having had at least two adequate dose-duration antidepressant medication failures in the current depressive episode.
5. current treatment drugs were stably used for at least 4 weeks

Exclusion criteria

1. MDD with psychosis, e.g., bipolar disorder, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, panic disorder, et al
2. Drug, tobacco or alcohol abuse
3. active suicidal intention
4. previous administration of NMDA receptor antagonists (e.g., ketamine)
5. previous (<6 weeks prior) or ongoing treatment with electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS)
6. pregnancy or breastfeeding
7. morbidly obese, BMI>35kg/m2
8. other diseases that could interfere with the results

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 2 patient groups, including a placebo group

sevoflurane

Experimental group

Description:

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

Treatment:

Drug: Sevoflurane

Drug: Placebo

placebo

Placebo Comparator group

Description:

Those with 1-hour inhalation of 30% oxygen

Treatment:

Drug: Placebo