Status:
UNKNOWN
OxPALM: Oxford Study on Probiotics and Low Mood
Lead Sponsor:
University of Oxford
Conditions:
Mood
Cognitive Change
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
Probiotics are live bacteria which have been suggested to have beneficial effects not only on gut function but also on psychological and cognitive functioning. This study will investigate how a specif...
Detailed Description
Current antidepressant treatments, which largely target monoamine pathways, are efficacious in treating many aspects of major depression, however it is estimated that more than 30% of depressed patien...
Eligibility Criteria
Inclusion
- Participants are willing and able to give informed consent for participation in the study.
- Male or female, aged between 18 and 55 years.
- Body mass index (BMI) within the range of 18.5 - 30 kg/m2.
- Sufficiently fluent in English to understand the tasks and instructions.
- Score between 5 and 19 on the Patient Health Questionnaire (PHQ-9).
- Participants not judged to be at risk of suicide or self-harm (as measured using the SCID) and/or in need of immediate treatment to the discretion of the Investigators.
Exclusion
- Current history of Axis I psychiatric disorder except for depression or anxiety;
- Current intake (or intention to take) any medication that may affect the outcomes, including medications affecting brain processing, sedation, and motility (examples include antidepressants, anxiolytics, among others);
- Current psychological therapy;
- Major medical disorders (including diseases affecting the human gastrointestinal tract);
- Intake of any other food supplements which, in the opinion of the Investigators, may affect the results;
- Any significant change in diet which, to the discretion of the Investigators, may affect the results;
- Recent participation in another research trial which, to the discretion of the Investigators, may affect the results (for example, using the same / a similar battery of cognitive / emotional tasks in the last 3 months);
- Dyslexia (given the nature of the computer tasks);
- Any other significant finding arising during the screening/selection process which, in the opinion of the Investigators, may influence the participant's ability to take part in the study or the study results.
Key Trial Info
Start Date :
August 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03801655
Start Date
August 15 2018
End Date
August 15 2020
Last Update
January 11 2019
Active Locations (1)
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1
Warneford Hospital
Oxford, Oxfordshire, United Kingdom, OX3 7JX