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Trial registered on ANZCTR


Registration number
ACTRN12614000544673
Ethics application status
Approved
Date submitted
16/05/2014
Date registered
21/05/2014
Date last updated
1/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Probiotics and Orotic Acid and antidepressant medication for treatment resistant depression; a pilot study
Scientific title
Probiotics and Orotic Acid as an adjuvant to antidepressant medication in the treatment of resistant depression with high risk of relapse.
Secondary ID [1] 284610 0
Nil Known
Universal Trial Number (UTN)
U1111-1156-8793
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
treatment resistant depression with high relapse risk 291913 0
Condition category
Condition code
Mental Health 292259 292259 0 0
Depression
Alternative and Complementary Medicine 292260 292260 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The project intervention will consist of an initial pilot phase of n=30 participants to gain initial efficacy data for probiotics and orotic acid by first taking probiotics for 4 weeks, and then adding orotic acid for 4 weeks. A single group trial will be conducted to identify the strength of signal for probiotics as opposed to orotic acid based on our previous research. A range of psychiatric measures will be used, with weekly scoring of symptom response.
The study duration is 8 weeks with 8 week follow up based on our previous studies this is the typical time point were maximum treatment effect, or early signs of relapse occur in this group. For 4 weeks participants will take 2 x probiotic capsules a day and 2 x prbiotic capsules and 4 x orotate tablets a day.

The products to be used: 1. A daily dose of 2 x probiotic capsules daily taken orally with food . 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 taken with food 4 x daily. 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.
Intervention code [1] 289383 0
Treatment: Other
Comparator / control treatment
Pilot study 1 will be a single group design

Control group
Uncontrolled

Outcomes
Primary outcome [1] 292129 0
BDI beck depression inventory <10 will be used for baseline and endpoint assessment of depressive symptoms
Timepoint [1] 292129 0
Intake and week 8, and at follow up week x 8 post study endpoint

Secondary outcome [1] 308238 0
OQ45 outcome questionnaire clinical function scale <63

maps changes in functioning
Timepoint [1] 308238 0
OQ45 at Intake, and x 8 weeks treatment endpoint and at follow up, week 16,


Secondary outcome [2] 308240 0
QOL administered at Intake, and at week 8 and again at followup week 16.

Timepoint [2] 308240 0
Time points are intake, week 4, week 8 treatment endpoint, and week 16 follow up assessment.
.

Eligibility
Key inclusion criteria
1. Be depressed, even though you are taking SSRI antidepressant medication as prescribed by their doctor
2. Currently be under the management of a medical practitioner e.g. your family doctor or a psychiatrist
3. Have a history of depression that has not responded well to medication, with at least 2 previous episodes
4. Be over 18 years of age and have the capacity to provide informed consent
5. Have the willingness and ability to comply with assessment protocols of the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Resistant depression not being the primary diagnosis
2. current substance misuse
3. other psychiatric disorder as primary diagnosis
4. active suicidality
5. not able to understand or conform to study requirements
6. Subject to a mental health or guardianship order

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Pilot single group n=30 recruited from the community.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be as recruited and allocated to single condition
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed using an intention to treat model in a Repeated Measures ANOVA design.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/08/2015
Actual
22/02/2016
Date of last participant enrolment
Anticipated
30/09/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 289243 0
Charities/Societies/Foundations
Name [1] 289243 0
NAB Foundation Trust
Country [1] 289243 0
Australia
Primary sponsor type
University
Name
university of Queensland
Address
School of Medicine

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

Country
Australia
Secondary sponsor category [1] 287917 0
None
Name [1] 287917 0
Address [1] 287917 0
Country [1] 287917 0
Other collaborator category [1] 278926 0
Individual
Name [1] 278926 0
Prof Luis Vittetta
Address [1] 278926 0
University of Sydney
Sydney Medical School
Edward Ford Building A27
The University of Sydney
NSW 2006
AUSTRALIA
Country [1] 278926 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291012 0
Behavioural & Social Sciences Ethical Review Committee (BSSERC) and Medical Research Ethics Committee (MREC)University of Queensland
Ethics committee address [1] 291012 0
Research & Research Training Division
Cumbrae-Stewart Building (72)
The University of Queensland
St Lucia Brisbane QLD 4072
Ethics committee country [1] 291012 0
Australia
Date submitted for ethics approval [1] 291012 0
Approval date [1] 291012 0
21/03/2014
Ethics approval number [1] 291012 0
2012000647

Summary
Brief summary
The aim of this pilot research is a simple test of probiotics to improve dysbiosis as a hypothesised casual factor in resistant depression and orotic acid as a treatment in conjunction wit SSRI medication. The signal group design is to establish signals for these approaches to provide preliminary efficacy data.



Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48446 0
Dr Matthew Bambling
Address 48446 0
School of Medicine

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

Country 48446 0
Australia
Phone 48446 0
+61 7 336 55148
Fax 48446 0
Email 48446 0
[email protected]
Contact person for public queries
Name 48447 0
Dr Matthew Bambling
Address 48447 0
School of Medicine

The University of Queensland
Mayne Medical School
288 Herston Road, Herston
Brisbane, QLD, 4006 Australia
Country 48447 0
Australia
Phone 48447 0
+61 7 336 55148
Fax 48447 0
Email 48447 0
[email protected]
Contact person for scientific queries
Name 48448 0
Dr Matthew Bambling
Address 48448 0
School of Medicine

The University of Queensland
Mayne Medical School
288 Herston Road, Herston
Brisbane, QLD, 4006 Australia
Country 48448 0
Australia
Phone 48448 0
+61 7 336 55148
Fax 48448 0
Email 48448 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA combination of probiotics and magnesium orotate attenuate depression in a small SSRI resistant cohort: an intestinal anti-inflammatory response is suggested.2017https://dx.doi.org/10.1007/s10787-017-0311-x
EmbaseS-adenosylmethionine (SAMe) and Magnesium Orotate as adjunctives to SSRIs in sub-optimal treatment response of depression in adults: A pilot study.2015https://dx.doi.org/10.1016/j.aimed.2015.04.003
N.B. These documents automatically identified may not have been verified by the study sponsor.