Probiotics and Orotic Acid and antidepressant medication for treatment resistant depression; a pilot study

INTERVENTION: 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. CONDITION: treatment resistant depression with high relapse risk PRIMARY OUTCOME: BDI beck depression inventory <10 will be used for baseline and endpoint assessment of depressive symptoms SECONDARY OUTCOME: OQ45 outcome questionnaire clinical function scale <63 ; ; maps changes in functioning QOL administered at Intake, and at week 8 and again at followup week 16. ; ; 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