Human Microbiota Transfer Therapy as an adjunctive treatment for Major Depressive Disorder in adults: a pilot randomised controlled trial

Deakin University0 个研究点目标入组 15 人开始时间: 2021年7月16日最近更新: 2022年11月28日

适应症

试验速览

暂无简介。

•Adults (age 18-65)
•MDD according to Structured Clinical Interview for DSM-5 (SCID-5) MDD module
•Moderate-to-severe score on MADRS (i.e. score of greater than or equal to 20)
•Have been on stable pharmaceutical treatment for MDD for one month prior to commencing trial

•Active suicidality (a MADRS suicide item score of 5 or 6)
•Use of probiotics, antibiotics or any experimental drug in the one month prior to study entry
•Serious gastrointestinal conditions (including inflammatory bowel disease, bowel cancer, diverticular disease, or a history of major bowel surgery, but not including irritable bowel syndrome, chronic diarrhoea or constipation)
•Pregnancy or breastfeeding (pregnancy will be determined in females using a urine pregnancy test at baseline)
•Comorbid psychiatric disturbances including bipolar disorder, a primary psychotic illness, obsessive-compulsive disorder, anorexia nervosa or bulimia nervosa
•Active substance-use disorder, defined as a score of 6 or greater on the brief Drug Abuse Screening Test (DAST-10), and/or a score of 16 or greater in the Alcohol Use Disorders Identification Test (AUDIT)
•Inability to read and understand the participant information and informed consent form
•Patients with a history of severe anaphylactic or anaphylactoid food allergy
•A condition that would jeopardize the safety or rights of the subject, would make it unlikely for the subject to complete the study, or would confound the results of the study

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