None listed
Conditions
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.
Interventions
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
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.
Sponsors
university of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed