A Probiotic and Magnesium orotate combination for the treatment of depression.
- Conditions
- DepressionMental Health - DepressionAlternative and Complementary Medicine - Other alternative and complementary medicine
- Registration Number
- ACTRN12617000419369
- Lead Sponsor
- Medlab Clinical LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 130
Participants meeting all of the following inclusion criteria will be included in the study: Given that there is personality and mood factors that are involved with the assessment and treatment of depression, comprehensive assessment and management criteria has been developed to ensure a representative sample and participant safety.
•Participants are diagnosed with depression by a health practitioner.
•Participants have not changed the standard care that they are receiving without consulting a primary care physician regardless of clinical improvement during the study.
•Participants that present with a high degree of comorbidity on Axis I, II, III (ICD-DSM criterion) will be accepted into the study, given that complex mood, personality and health problems are common in patients diagnosed with depression.
•Eligible participants will be 18 years of age with no upper age limit.
•Participants will be asked not to be currently administering any nutritional supplements or any herbal medicines that have been shown to have antidepressant effects (a list will be provided to participants).
•Participants will be advised not to self-medicate” with probiotic supplements or any prebiotic supplements for the duration of the trial.
•Participants will not have been diagnosed with major depression as the primary condition.
•Participants diagnosed with co-morbid schizophrenia, depression as part of bipolar, or current substance misuse will not be eligible.
•Participants with current high suicide risk will not be eligible.
•Participants prescribed any form of antibiotics, currently or during previous 4 weeks may be considered for inclusion (if last 4 weeks, wait for entry).
•Patients currently administering Warfarin will not be eligible.
•Participants who are pregnant or planning pregnancy over 16 weeks will not be eligible.
•Serious physical illness (e.g., serious life threatening illness or palliative care)
•Participants administering medications other than SSRIs/SNRIs, or, SSRIs/SNRIs in conjunction with other antidepressants will not be eligible.
•Participants already taking probiotics under advisement of a health professional will not be eligible.
•Participants with an established or suspected obstructive/central sleep apnoea.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of participants with Beck Depression inventory >10 indicating symptom remission<br>[Intake (initial assessment before starting), 2 months to treatment endpoint (completion of the 8 week intervention period) and again at 2 month follow up.];Incidence of dysbiosis assessed by fecal analysis, [Fecal tests at intake (initial assessment before starting), and at 2 months treatment endpoint which is the completion of the 8 week intervention period.]
- Secondary Outcome Measures
Name Time Method Proportion of participants with a reduction in the inflammatory marker LPS from baseline, assessed using blood samples and analysis. <br>[Blood tests at intake (initial assessment before starting), and at 2 months treatment endpoint which is the completion of the 8 week intervention period.];Proportion of increased participant Quality of Life Quality of Life Scale (QOLS) from baseline. <br>[Intake (initial assessment before starting), 2 months to treatment endpoint (completion of the 8 week intervention period) and again at 2 month follow up.];Proportion of participants on the Outcome Questionnaire(OQ 45) > 63 which indicates non clinical levels of symptom, interpersonal and social function distress. [Intake (initial assessment before starting), weekly to treatment endpoint (completion of the 8 week intervention period) and again at 2 month follow up.]