Detoxification From the Lipid Tract

NCT06357104 | Completed Phase 4

• 1 other identifier: SCI-CT-0001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Apart from electroencephalogram biofeedback and electrical brain stimulation adopted for maintenance treatment, the study utilizes ultra-low frequency transcranial magnetic stimulation (ULF-TMS) for initial γ-aminobutyric acid (GABA) stimulation. The cocktail therapy starts after the primary efficacy endpoint, and concomitant therapy is adopted throughout the study.

Conditions

COVID-19 Vaccine Adverse Reaction

Keywords

sebaceous immunobiology; lipid; depression

Outcome Measures

Primary Outcomes (12)

• Changes in Leukocyte and Components' Quantities

  All white blood cells are evaluated.

  24 days

• Changes in Leukocyte Components' Ratios

  All white blood cells are evaluated.

  24 days

• Quantity Changes in Megakaryocyte-Erythroid Progenitor

  24 days

• Changes in Hemoglobin Distribution

  24 days

• Changes in Mean Corpuscular Hemoglobin

  24 days

• Changes in Hematocrit

  24 days

• Changes in Plateletcrit

  24 days

• Red cell Distribution Width Coefficient of Variation

  24 days

• Changes in Particulate Matter Sizes

  24 days

• Changes in Total Lipid Quantities

  24 days

• Changes in Apolipoproteina

  24 days

• Changes in Lipoprotein (a)

  24 days

Secondary Outcomes (2)

• Blood Pressure Changes

  24 days

• Heart Rate Changes

  24 days

Study Arms (1)

GABA Cocktail

EXPERIMENTAL

Device: electroencephalogram biofeedback; Device: electrical brain stimulation; Device: ultra-low frequency transcranial magnetic stimulation; Drug: Sertraline Hydrochloride; Drug: Clonazepam; Drug: Alprazolam; Drug: Metoprolol; Drug: Olanzapine; Drug: Pravastatin Sodium 20 MG; Drug: Sacubitril Valsartan Sodium Hydrate

Interventions

electroencephalogram biofeedback DEVICE

EB is conducted for 20 minutes per section with two sections per day in the primary efficacy endpoint.

Also known as: EB

GABA Cocktail

electrical brain stimulation DEVICE

EBS is conducted for 20 minutes per section per day in the primary efficacy endpoint.

Also known as: EBS

GABA Cocktail

ultra-low frequency transcranial magnetic stimulation DEVICE

ULF-TMS is conducted mainly for the left side of the participant's brain for 20 minutes per section per day in the primary efficacy endpoint.

Also known as: ULF-TMS

GABA Cocktail

Sertraline Hydrochloride DRUG

Sertraline is taken in the morning for 150 mg per day.

Also known as: SSRI

GABA Cocktail

Clonazepam DRUG

Clonazepam is taken in the morning for 1 mg per day.

GABA Cocktail

Alprazolam DRUG

Alprazolam is introduced near the end of the primary efficacy endpoint for 0.4 mg per night.

GABA Cocktail

Metoprolol DRUG

Metoprolol is introduced at the secondary efficacy endpoint starting with 47.5 mg per night and increase to 95 mg per night.

Also known as: beta blocker

GABA Cocktail

Olanzapine DRUG

Olanzapine is taken throughout the trial with 7.5 mg per night at first, and increases to 10 mg per night after the cocktail therapy.

GABA Cocktail

Pravastatin Sodium 20 MG DRUG

Pravastatin sodium is introduced in the secondary efficacy endpoint with 20 mg per night.

GABA Cocktail

Sacubitril Valsartan Sodium Hydrate DRUG

Sacubitril valsartan sodium is introduced in the secondary efficacy endpoint with 100 mg per day.

Also known as: ARNI

GABA Cocktail

Eligibility Criteria

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

You may qualify if:

• People who received full doses of COVID-19 vaccines.

You may not qualify if:

• Women during pregnancy.

Sponsors & Collaborators

• Pachankis, Yang I., M.D.: lead
• First Affiliated Hospital of Chongqing Medical University: collaborator

Study Sites (1)

Residential Address

Chongqing, Chongqing Municipality, 402762, China

Location

Related Publications (20)

• Kim H, Nobeyama T, Honda S, Yasuda K, Morone N, Murakami T. Membrane fusogenic high-density lipoprotein nanoparticles. Biochim Biophys Acta Biomembr. 2019 Oct 1;1861(10):183008. doi: 10.1016/j.bbamem.2019.06.007. Epub 2019 Jun 15.

  PMID: 31207206 BACKGROUND

• Zhao M, Luo Z, He H, Shen B, Liang J, Zhang J, Ye J, Xu Y, Wang Z, Ye D, Wang M, Wan J. Decreased Low-Density Lipoprotein Cholesterol Level Indicates Poor Prognosis of Severe and Critical COVID-19 Patients: A Retrospective, Single-Center Study. Front Med (Lausanne). 2021 May 26;8:585851. doi: 10.3389/fmed.2021.585851. eCollection 2021.

  PMID: 34124081 BACKGROUND

• Glebov OO. Understanding SARS-CoV-2 endocytosis for COVID-19 drug repurposing. FEBS J. 2020 Sep;287(17):3664-3671. doi: 10.1111/febs.15369. Epub 2020 Jun 2.

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• Pachankis YI. Plausibility Review on Lipoprotein (A) Infection Path of S2 Autoimmune Pathogen. Global Journal of Medical Research. 2023;23(3)(C):5-11.

  BACKGROUND

• Yang Y, Lian YT, Huang SY, Yang Y, Cheng LX, Liu K. GABA and topiramate inhibit the formation of human macrophage-derived foam cells by modulating cholesterol-metabolism-associated molecules. Cell Physiol Biochem. 2014;33(4):1117-29. doi: 10.1159/000358681. Epub 2014 Apr 9.

  PMID: 24733016 BACKGROUND

• Lombardi JP, Kinzlmaier DA, Jacob TC. Visualizing GABA A Receptor Trafficking Dynamics with Fluorogenic Protein Labeling. Curr Protoc Neurosci. 2020 Jun;92(1):e97. doi: 10.1002/cpns.97.

  PMID: 32364672 BACKGROUND

• Griffin CE 3rd, Kaye AM, Bueno FR, Kaye AD. Benzodiazepine pharmacology and central nervous system-mediated effects. Ochsner J. 2013 Summer;13(2):214-23.

  PMID: 23789008 BACKGROUND

• Al-Tubuly R, Aburawi S, Alghzewi E, Gorash Z, Errwami S. The effect of sympathetic antagonists on the antidepressant action of alprazolam. Libyan J Med. 2008 Jun 1;3(2):78-83. doi: 10.4176/080101.

  PMID: 21499463 BACKGROUND

• Hunninghake D, Wallace RB, Reiland S, Barrett-Connor E, Wahl P, Hoover J, Heiss G. Alterations of plasma lipid and lipoprotein levels associated with benzodiazepine use--the LRC Program Prevalence Study. Atherosclerosis. 1981 Oct;40(2):159-65. doi: 10.1016/0021-9150(81)90034-4.

  PMID: 6118165 BACKGROUND

• McGrath M, Hoyt H, Pence A, Forman SA, Raines DE. Selective actions of benzodiazepines at the transmembrane anaesthetic binding sites of the GABAA receptor: In vitro and in vivo studies. Br J Pharmacol. 2021 Dec;178(24):4842-4858. doi: 10.1111/bph.15662. Epub 2021 Sep 26.

  PMID: 34386973 BACKGROUND

• Mascarenhas FNADP, Silva NF, Menezes-Reis LT, Vieira LG, Hirano LQL, Botelho FV, Ribeiro DL, Zanon RG. Prenatal effects of alprazolam treatment on the immature cerebellum of rats. Int J Dev Neurosci. 2022 Dec;82(8):727-735. doi: 10.1002/jdn.10222. Epub 2022 Aug 5.

  PMID: 35916248 BACKGROUND

• Elgarf AA, Siebert DCB, Steudle F, Draxler A, Li G, Huang S, Cook JM, Ernst M, Scholze P. Different Benzodiazepines Bind with Distinct Binding Modes to GABAA Receptors. ACS Chem Biol. 2018 Aug 17;13(8):2033-2039. doi: 10.1021/acschembio.8b00144. Epub 2018 Jul 23.

  PMID: 29767950 BACKGROUND

• Pachankis YI. Adrenaline Intolerance in ASD Curing From Autoimmune Pathogens - Sebaceous Immunobiology in Autoimmune Pathogen Research. Biomedical Review: Journal of Basic and Applied Medical Sciences. 2023;10(1):8-14.

  BACKGROUND

• Kottyan LC, Collier AR, Cao KH, Niese KA, Hedgebeth M, Radu CG, Witte ON, Khurana Hershey GK, Rothenberg ME, Zimmermann N. Eosinophil viability is increased by acidic pH in a cAMP- and GPR65-dependent manner. Blood. 2009 Sep 24;114(13):2774-82. doi: 10.1182/blood-2009-05-220681. Epub 2009 Jul 29.

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• Cao Z, Zhao M, Sun H, Hu L, Chen Y, Fan Z. Roles of mitochondria in neutrophils. Front Immunol. 2022 Aug 19;13:934444. doi: 10.3389/fimmu.2022.934444. eCollection 2022.

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• Fox S, Leitch AE, Duffin R, Haslett C, Rossi AG. Neutrophil apoptosis: relevance to the innate immune response and inflammatory disease. J Innate Immun. 2010;2(3):216-27. doi: 10.1159/000284367. Epub 2010 Feb 11.

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• Parihar A, Eubank TD, Doseff AI. Monocytes and macrophages regulate immunity through dynamic networks of survival and cell death. J Innate Immun. 2010;2(3):204-15. doi: 10.1159/000296507. Epub 2010 Mar 16.

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• Salih RQ, Salih GA, Abdulla BA, Ahmed AD, Mohammed HR, Kakamad FH, Salih AM. False-positive HIV in a patient with SARS-CoV-2 infection; a case report. Ann Med Surg (Lond). 2021 Nov;71:103027. doi: 10.1016/j.amsu.2021.103027. Epub 2021 Nov 6.

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  PMID: 32642434 BACKGROUND

Related Links

• Benzodiazepines drug profile. European Monitoring Centre for Drugs and Drug Addiction.
• Antianxiety Drugs Successfully Treat Autism

MeSH Terms

Conditions

Depression

Interventions

Deep Brain Stimulation; Sertraline; Clonazepam; Alprazolam; Metoprolol; Adrenergic beta-Antagonists; Olanzapine; Pravastatin; sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative; 1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: April 10, 2024
• Study Start: February 26, 2024
• Primary Completion: March 14, 2024
• Study Completion: March 20, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

CN (1)