The efficacy of a probiotic supplement in the treatment of depressive symptomatology in volunteers with moderate to very severe depression:An open label trial using a micronutrient formula in non-responders.

Julia Rucklidge0 个研究点目标入组 15 人开始时间: 2013年9月24日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Must have been a participant in a previous study: An intervention using probiotics for depressive symptoms (Trial ID ACTRN12613000438752).
•Must be a non-responder to the probiotic treatment after the open label phase. A response is classified as >50% change on MADRS (primary outcome measure).
•Must have a MADRS score of >19 (moderate depression) at beginning of trial.

•Identical to exclusion criteria for probiotic trial, as no new participants will be recruited (Trial ID ACTRN12613000438752).
•Neurological disorder involving brain or other central function (e.g., epilepsy, MS, narcolepsy).
•Any serious medical condition for which major medical interventions are anticipated during the duration of the trial.
•Any patient known to be allergic to the ingredients of the intervention.
•Pregnancy or breastfeeding.
•Any other medication with primarily central nervous system activity, including mood stabilizers. Participants must have been off of these medications for a minimum of four weeks prior to the trial.
•Patients will be excluded temporarily if they have taken an oral antibiotic in the previous 6 weeks. If an antibiotic is begun during the course of the trial, that patient will be withdrawn from the study.
•Any subject judged clinically to be at serious risk for suicide or violence in the opinion of the researchers.
•Participants will be asked to minimize their intake of colas, tea, coffee, alcohol, cigarettes and illicit drugs. These substances will be monitored as part of the trial.
•Participants will be excluded if they take any antidepressant herbal supplement, including St John’s Wort and 5-HTP.
•Renal, hepatic, cardiovascular and respiratory diseases
•Any person whose immune system is known to be weakened (e.g. by HIV/AIDS, a genetic defect, long-term use of corticosteroids or taking immunosuppressive medications).

发起方

Julia Rucklidge