Human Microbiota Transfer Therapy for Depression (The Moving Moods Pilot Study)
- Conditions
- Major Depressive DisorderMental Health - Depression
- Registration Number
- ACTRN12621000932864
- Lead Sponsor
- Deakin University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 15
•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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method