Sevoflurane for Treatment-Resistant Depression

NCT05008939 | Unknown DMC

• 1 other identifier: ShanghaiFMIH2021 Zhiqiang Liu
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder, Treatment-Resistant; Depressive Disorder, Major

Keywords

treatment-resistant depression (TRD); major depressive disorder (MDD); sevoflurane

Outcome Measures

Primary Outcomes (1)

• Rates of treatment responses in 17-item Hamilton Depression Rating Scale (HDRS-17)

  ≥50% HDRS-17 reduction in depressive symptoms

  24 hours after the end of treatment

Secondary Outcomes (11)

• Rates of treatment responses in HDRS-17

  2 hours, 7 days,14 days and 28 days after the end of treatment

• Rates of remissions in HDRS-17

  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

• Rates of remissions in MADRS

  2 hours, 24 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

Study Arms (2)

sevoflurane

EXPERIMENTAL

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

Drug: Sevoflurane; Drug: Placebo

placebo

PLACEBO COMPARATOR

Those with 1-hour inhalation of 30% oxygen

Drug: Placebo

Interventions

Sevoflurane DRUG

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

Also known as: Treatment

sevoflurane

Placebo DRUG

Patients received 30% oxygen for 1 hour.

Also known as: Control

placebo; sevoflurane

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai First Maternity and Infant Hospital: lead
• Shanghai Pudong New Area Mental Health Center: collaborator

Study Sites (1)

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

Shanghai, Shanghai Municipality, 02148, China

Location

Related Publications (11)

• 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.

  PMID: 19880458 BACKGROUND

• 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.

  PMID: 16390886 BACKGROUND

• 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.

  PMID: 24789696 BACKGROUND

• 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.

  PMID: 14658951 BACKGROUND

• 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.

  PMID: 21734685 BACKGROUND

• 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.

  PMID: 17444078 BACKGROUND

• 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.

  PMID: 25767082 BACKGROUND

• 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.

  PMID: 25533726 BACKGROUND

• 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.

  PMID: 26991409 BACKGROUND

• 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.

  PMID: 26400403 BACKGROUND

• 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.

  PMID: 31368063 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depressive Disorder, Major

Interventions

Sevoflurane; Therapeutics

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Zhiqiang Liu, MD

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

  STUDY CHAIR

Central Study Contacts

Fuyi Shen, MD

CONTACT

86-13524123072; shenfuyi315@sina.com

Zhiqiang Liu, MD

CONTACT

86-13816877756; drliuzhiqiang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2021
• First Posted: August 17, 2021
• Study Start: August 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)