Back to resultsSevoflurane for Treatment-Resistant Depression
Primary Purpose
Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sevoflurane
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder, Treatment-Resistant focused on measuring treatment-resistant depression (TRD), major depressive disorder (MDD), sevoflurane
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
Sites / Locations
- Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
sevoflurane
placebo
Arm Description
Those with 1-hour inhalation of 1% sevoflurane/30% oxygen
Those with 1-hour inhalation of 30% oxygen
Outcomes
Primary Outcome Measures
Rates of treatment responses in 17-item Hamilton Depression Rating Scale (HDRS-17)
≥50% HDRS-17 reduction in depressive symptoms
Secondary Outcome Measures
Rates of treatment responses in HDRS-17
≥50% HDRS-17 reduction in depressive symptoms
Rates of remissions in HDRS-17
HDRS-17 ≤7 points
Rates of treatment responses in Montgomery-Åsberg Depression Rating Scale (MADRS)
≥50% MADRS reduction in the baseline score
Rates of remissions in MADRS
MADRS <10
The assessment of depression with self-rating scale
The changes of score in Patient Health Questionnaire-9 (PHQ-9)
The assessment of anxiety by psychiatrist
The changes of score in Hamilton Anxiety Rating Scale (HAMA)
The assessment of anxiety with self-rating scale
The changes of score in Generalized Anxiety Disorder Screener (GAD-7)
The assessment of improvement by psychiatrist
The changes of score in Clinical Global Impression (CGI)
The assessment of improvement with self-rating scale
The changes of score in Patient Global Impressions of Improvement (PGI-I)
The assessment of side effects with self-rating scale
Including Patient Rated Inventory of Side Effects (PRISE)
Side effects of sevoflurane
Including nausea, vomiting, headache, dizzy, hypotension, hypoxemia, carbon dioxide accumulation, et al
Full Information
NCT ID
NCT05008939
First Posted
July 25, 2021
Last Updated
August 12, 2021
Sponsor
Shanghai First Maternity and Infant Hospital
Collaborators
Shanghai Pudong New Area Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT05008939
Brief Title
Sevoflurane for Treatment-Resistant Depression
Official Title
Subanesthetic Sevoflurane for Treatment-Resistant Depression: A Proof-of-Concept Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2021 (Anticipated)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai First Maternity and Infant Hospital
Collaborators
Shanghai Pudong New Area Mental Health Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major
Keywords
treatment-resistant depression (TRD), major depressive disorder (MDD), sevoflurane
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sevoflurane
Arm Type
Experimental
Arm Description
Those with 1-hour inhalation of 1% sevoflurane/30% oxygen
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Those with 1-hour inhalation of 30% oxygen
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Treatment
Intervention Description
Patients receive 1% sevoflurane and 30% oxygen for 1 hour.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Control
Intervention Description
Patients received 30% oxygen for 1 hour.
Primary Outcome Measure Information:
Title
Rates of treatment responses in 17-item Hamilton Depression Rating Scale (HDRS-17)
Description
≥50% HDRS-17 reduction in depressive symptoms
Time Frame
24 hours after the end of treatment
Secondary Outcome Measure Information:
Title
Rates of treatment responses in HDRS-17
Description
≥50% HDRS-17 reduction in depressive symptoms
Time Frame
2 hours, 7 days,14 days and 28 days after the end of treatment
Title
Rates of remissions in HDRS-17
Description
HDRS-17 ≤7 points
Time Frame
2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment
Title
Rates of treatment responses in Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
≥50% MADRS reduction in the baseline score
Time Frame
2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment
Title
Rates of remissions in MADRS
Description
MADRS <10
Time Frame
2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment
Title
The assessment of depression with self-rating scale
Description
The changes of score in Patient Health Questionnaire-9 (PHQ-9)
Time Frame
2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment
Title
The assessment of anxiety by psychiatrist
Description
The changes of score in Hamilton Anxiety Rating Scale (HAMA)
Time Frame
2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment
Title
The assessment of anxiety with self-rating scale
Description
The changes of score in Generalized Anxiety Disorder Screener (GAD-7)
Time Frame
2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment
Title
The assessment of improvement by psychiatrist
Description
The changes of score in Clinical Global Impression (CGI)
Time Frame
2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment
Title
The assessment of improvement with self-rating scale
Description
The changes of score in Patient Global Impressions of Improvement (PGI-I)
Time Frame
2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment
Title
The assessment of side effects with self-rating scale
Description
Including Patient Rated Inventory of Side Effects (PRISE)
Time Frame
2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment
Title
Side effects of sevoflurane
Description
Including nausea, vomiting, headache, dizzy, hypotension, hypoxemia, carbon dioxide accumulation, et al
Time Frame
up to 2 hours after the end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fuyi Shen, MD
Phone
86-13524123072
Email
shenfuyi315@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiqiang Liu, MD
Phone
86-13816877756
Email
drliuzhiqiang@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhiqiang Liu, MD
Organizational Affiliation
Department of Anesthesiaology, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
02148
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuyi Shen, MD
Phone
86-13524123072
Email
shenfuyi315@sina.com
First Name & Middle Initial & Last Name & Degree
Zhiqiang Liu, MD
Phone
86-13816877756
Email
drliuzhiqiang@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19880458
Citation
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Sevoflurane for Treatment-Resistant Depression
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