A randomised placebo controlled clinical trial investigating the role of a combination of probiotics and magnesium orotate for the management of depression

Medlab Clinical LTD0 个研究点目标入组 130 人开始时间: 2017年3月23日最近更新: 2018年11月12日

适应症

试验速览

暂无简介。

•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.

发起方