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Clinical Trials/NCT05008939
NCT05008939UnknownNot Applicable

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

Shanghai First Maternity and Infant Hospital1 site in 1 country15 target enrollmentStarted: August 2021Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Enrollment
15
Locations
1
Primary Endpoint
Rates of treatment responses in 17-item Hamilton Depression Rating Scale (HDRS-17)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Experimental

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

Intervention: Sevoflurane (Drug)

sevoflurane

Experimental

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

Intervention: Placebo (Drug)

placebo

Placebo Comparator

Those with 1-hour inhalation of 30% oxygen

Intervention: Placebo (Drug)

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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