NRGBiotic™

Depression
ANZCTR: ACTRN12614000544673
Date Started: 2014-03-21
Progress - FIH Safety & Efficacy - Not Recruiting

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Study Site:

The University of Queensland Mayne Medical School 288 Herston Road, Herston Brisbane, QLD, 4006 Australia

Formulation:

  1. A daily dose of 2 x probiotic capsules. Each capsule contains 50 billion colony-forming units (CFU) of live organisms (Lactobacillus acidophilus +Lactobacillus casei +Lactobacillus rhamnosus JB-1.). the probiotic will be taken in addition to a prescribed dose of SSRI medication for participants with a demonstrated history of chronic treatment resistant depression.
     
  2. A daily dose of 1600mg of Orotic acid in the magnesium orotate form. Magnesium orotate will be taken in addition to a prescribed dose of SSRI medication for participants with a demonstrated history of chronic treatment resistant depression.

About Trial:

A Phase I safety and exploratory end-point trial investigating the role of Probiotics and Magnesium Orotate [NRGBiotic™] co-administered with Antidepressant Medications for the Management of Treatment Resistant Depression

 

Prior trials:

NRGBiotic™ [Pilot 1] A randomised placebo-controlled clinical trial investigating the role of a combination of probiotics and magnesium orotate for the management of depression.

Date started: 13/02/2017

HREC name: QUT Office of Research Ethics and Integrity / The University Of Queensland Institutional Human Research Ethics Committee A.

HREC Approval ID: / 2017000186

CTN: CT- CT-2017-CTN-01080-1 v3

ANZCTR: ACTRN12617000419369

Study site: Queensland University of Technology, 2 George Street, Brisbane City, QLD, 4000.

 

Magnesium Orotate: The effect of 1600mg daily dosage of Magnesium supplementation as an augment to SSRI medication on the clinical symptoms of patients with treatment-resistant depression: a pilot study. 

Date started: 21/04/2014

HREC Name: Behavioural & Social Sciences Ethical Review Committee (BSSERC) and Medical Research Ethics Committee (MREC)University of Queensland.

HREC Approval ID: 2012000647

AZNCTR: ACTRN12614000574640

Study site: Royal Brisbane and Women’s Hospital – Department of Psychiatry

HREC Date:

2014-03-21

HREC Date:

2014-03-21

HREC ID:

2012000647

PUBLICATIONS OR CONFERENCES ASSOCIATED WITH THE PROGRAM

A combination of probiotics and magnesium orotate attenuate depression in a small SSRI resistant cohort: an intestinal anti-inflammatory response is suggested

Inflammopharmacology. 2017 Feb 2. doi: 10.1007/s10787-017-0311-x

Date:          2017-04-25

Authors:   Bambling M, Edwards SC, Hall S, Vitetta L

S-adenosylmethionine (SAMe) and Magnesium Orotate as adjunctives to SSRIs in sub-optimal treatment response of depression in adults; a pilot study

Advances in Integrative Medicine. 2015, 2(1):56-62

Date:          2015-04-01

Authors:   Bambling M, Edwards SC, Coulson S, Vitetta L

Depression and the Gut Microbiome Influence of Probiotics and Nutraceuticals

General Practice Conference and Exhibition [Sydney, Melbourne] 2015

Date:          2015-01-01

Authors:   Vitetta L, Coulson S

Invitation to speak at Opening Ceremony and Keynote Forum session: The Microbiome - A Universe of Therapeutic Potential.

BIT’s 14th Annual Congress of IDDST June 16-18, 2016. South Korea

Date:          2016-06-16

Authors:   Hall S

An evidence-based scale for the antecedents of depressive symptoms in Australian adults

Australas Psychiatry. 2016;24(5):466-469.

Date:          2016-10-01

Authors:   Liu X, Furuya-Kanamori L, Siskind D, Crompton D, Williams GM, Kostner K, Vitetta L, Doi SA

Mitochondria could be a potential key mediator linking the intestinal microbiota to depression

J Cell Biochem. 2020 Jan;121(1):17-24. doi: 10.1002/jcb.29311. Epub 2019 Aug 5.PMID: 31385365

Date:          2020-01-01

Authors:   Chen J, Vitetta L


PARTNER'S ASSOCIATED WITH THE PROGRAM

The University of Queensland

The University of Queensland

The University of Queensland is a public research university located primarily in Brisbane, the capital city of the Australian state of Queensland. This world-leading university was founded in 1909 by the state parliament and ranked equal second in Australia.

 

As of July 2020, it had over 54,000 students and 2,900+ academic staff.

 

For more information about The University of Queensland visit https://www.uq.edu.au/about/university-profile