Sevoflurane for Treatment-Resistant Depression

August 12, 2021 updated by: Shanghai First Maternity and Infant Hospital

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 02148
        • Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours after the end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of treatment responses in HDRS-17
Time Frame: 2 hours, 7 days,14 days and 28 days after the end of treatment
≥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
Time Frame: 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment
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)
Time Frame: 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment
≥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
Time Frame: 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment
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
Time Frame: 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)
2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment
The assessment of anxiety by psychiatrist
Time Frame: 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)
2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment
The assessment of anxiety with self-rating scale
Time Frame: 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)
2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment
The assessment of improvement by psychiatrist
Time Frame: 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)
2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment
The assessment of improvement with self-rating scale
Time Frame: 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)
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
Time Frame: 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment
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
Time Frame: up to 2 hours after the end of treatment
Including nausea, vomiting, headache, dizzy, hypotension, hypoxemia, carbon dioxide accumulation, et al
up to 2 hours after the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai First Maternity and Infant Hospital

Collaborators

Shanghai Pudong New Area Mental Health Center

Investigators

  • Study Chair: Zhiqiang Liu, MD, Department of Anesthesiaology, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

July 25, 2021

First Submitted That Met QC Criteria

August 12, 2021

First Posted (Actual)

August 17, 2021

Study Record Updates

Last Update Posted (Actual)

August 17, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShanghaiFMIH2021 Zhiqiang Liu

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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