Sevoflurane for Treatment-Resistant Depression

NCT ID: NCT05008939

Last Updated: 2021-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-31

Study Completion Date

2022-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Depressive Disorder, Treatment-Resistant Depressive Disorder, Major

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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sevoflurane

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

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Patients received 30% oxygen for 1 hour.

placebo

Those with 1-hour inhalation of 30% oxygen

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients received 30% oxygen for 1 hour.

Interventions

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Sevoflurane

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

Intervention Type DRUG

Placebo

Patients received 30% oxygen for 1 hour.

Intervention Type DRUG

Other Intervention Names

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Treatment Control

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Pudong New Area Mental Health Center

UNKNOWN

Sponsor Role collaborator

Shanghai First Maternity and Infant Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhiqiang Liu, MD

Role: STUDY_CHAIR

Department of Anesthesiaology, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine

Locations

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Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Fuyi Shen, MD

Role: CONTACT

86-13524123072

Zhiqiang Liu, MD

Role: CONTACT

86-13816877756

Facility Contacts

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Fuyi Shen, MD

Role: primary

86-13524123072

Zhiqiang Liu, MD

Role: backup

86-13816877756

References

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Gaynes BN, Warden D, Trivedi MH, Wisniewski SR, Fava M, Rush AJ. What did STAR*D teach us? Results from a large-scale, practical, clinical trial for patients with depression. Psychiatr Serv. 2009 Nov;60(11):1439-45. doi: 10.1176/ps.2009.60.11.1439.

Reference Type BACKGROUND
PMID: 19880458 (View on PubMed)

Trivedi MH, Rush AJ, Wisniewski SR, Nierenberg AA, Warden D, Ritz L, Norquist G, Howland RH, Lebowitz B, McGrath PJ, Shores-Wilson K, Biggs MM, Balasubramani GK, Fava M; STAR*D Study Team. Evaluation of outcomes with citalopram for depression using measurement-based care in STAR*D: implications for clinical practice. Am J Psychiatry. 2006 Jan;163(1):28-40. doi: 10.1176/appi.ajp.163.1.28.

Reference Type BACKGROUND
PMID: 16390886 (View on PubMed)

Mrazek DA, Hornberger JC, Altar CA, Degtiar I. A review of the clinical, economic, and societal burden of treatment-resistant depression: 1996-2013. Psychiatr Serv. 2014 Aug 1;65(8):977-87. doi: 10.1176/appi.ps.201300059.

Reference Type BACKGROUND
PMID: 24789696 (View on PubMed)

Papakostas GI, Petersen TJ, Farabaugh AH, Murakami JL, Pava JA, Alpert JE, Fava M, Nierenberg AA. Psychiatric comorbidity as a predictor of clinical response to nortriptyline in treatment-resistant major depressive disorder. J Clin Psychiatry. 2003 Nov;64(11):1357-61. doi: 10.4088/jcp.v64n1112.

Reference Type BACKGROUND
PMID: 14658951 (View on PubMed)

Collins PY, Patel V, Joestl SS, March D, Insel TR, Daar AS; Scientific Advisory Board and the Executive Committee of the Grand Challenges on Global Mental Health; Anderson W, Dhansay MA, Phillips A, Shurin S, Walport M, Ewart W, Savill SJ, Bordin IA, Costello EJ, Durkin M, Fairburn C, Glass RI, Hall W, Huang Y, Hyman SE, Jamison K, Kaaya S, Kapur S, Kleinman A, Ogunniyi A, Otero-Ojeda A, Poo MM, Ravindranath V, Sahakian BJ, Saxena S, Singer PA, Stein DJ. Grand challenges in global mental health. Nature. 2011 Jul 6;475(7354):27-30. doi: 10.1038/475027a. No abstract available.

Reference Type BACKGROUND
PMID: 21734685 (View on PubMed)

Berlim MT, Turecki G. Definition, assessment, and staging of treatment-resistant refractory major depression: a review of current concepts and methods. Can J Psychiatry. 2007 Jan;52(1):46-54. doi: 10.1177/070674370705200108.

Reference Type BACKGROUND
PMID: 17444078 (View on PubMed)

Sanacora G, Schatzberg AF. Ketamine: promising path or false prophecy in the development of novel therapeutics for mood disorders? Neuropsychopharmacology. 2015 Mar 13;40(5):1307. doi: 10.1038/npp.2014.338. No abstract available.

Reference Type BACKGROUND
PMID: 25767082 (View on PubMed)

Chen C, Ji M, Xu Q, Zhang Y, Sun Q, Liu J, Zhu S, Li W. Sevoflurane attenuates stress-enhanced fear learning by regulating hippocampal BDNF expression and Akt/GSK-3beta signaling pathway in a rat model of post-traumatic stress disorder. J Anesth. 2015 Aug;29(4):600-8. doi: 10.1007/s00540-014-1964-x. Epub 2014 Dec 23.

Reference Type BACKGROUND
PMID: 25533726 (View on PubMed)

Zhang H, Li L, Sun Y, Zhang X, Zhang Y, Xu S, Zhao P, Liu T. Sevoflurane prevents stroke-induced depressive and anxiety behaviors by promoting cannabinoid receptor subtype I-dependent interaction between beta-arrestin 2 and extracellular signal-regulated kinases 1/2 in the rat hippocampus. J Neurochem. 2016 May;137(4):618-29. doi: 10.1111/jnc.13613. Epub 2016 Mar 31.

Reference Type BACKGROUND
PMID: 26991409 (View on PubMed)

Luo C, Zhang YL, Luo W, Zhou FH, Li CQ, Xu JM, Dai RP. Differential effects of general anesthetics on anxiety-like behavior in formalin-induced pain: involvement of ERK activation in the anterior cingulate cortex. Psychopharmacology (Berl). 2015 Dec;232(24):4433-44. doi: 10.1007/s00213-015-4071-2. Epub 2015 Sep 24.

Reference Type BACKGROUND
PMID: 26400403 (View on PubMed)

Guo Z, Zhao F, Wang Y, Wang Y, Geng M, Zhang Y, Ma Q, Xu X. Sevoflurane Exerts an Anti-depressive Action by Blocking the HMGB1/TLR4 Pathway in Unpredictable Chronic Mild Stress Rats. J Mol Neurosci. 2019 Dec;69(4):546-556. doi: 10.1007/s12031-019-01380-2. Epub 2019 Jul 31.

Reference Type BACKGROUND
PMID: 31368063 (View on PubMed)

Other Identifiers

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ShanghaiFMIH2021 Zhiqiang Liu

Identifier Type: -

Identifier Source: org_study_id

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