Probiotics and Orotic Acid and antidepressant medication for treatment resistant depression; a pilot study

Phase 1

Completed

• Conditions: treatment resistant depression with high relapse risk; Mental Health - Depression; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12614000544673
• Lead Sponsor: university of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-21
• Study Completion: 2017-01-09
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1.Be depressed, even though you are taking SSRI antidepressant medication as prescribed by their doctor
2.Currently be under the management of a medical practitioner e.g. your family doctor or a psychiatrist
3.Have a history of depression that has not responded well to medication, with at least 2 previous episodes
4.Be over 18 years of age and have the capacity to provide informed consent
5.Have the willingness and ability to comply with assessment protocols of the study

Exclusion Criteria

1.Resistant depression not being the primary diagnosis
2.current substance misuse
3.other psychiatric disorder as primary diagnosis
4.active suicidality
5.not able to understand or conform to study requirements
6.Subject to a mental health or guardianship order

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BDI beck depression inventory <10 will be used for baseline and endpoint assessment of depressive symptoms [ Intake and week 8, and at follow up week x 8 post study endpoint <br><br>]

Secondary Outcome Measures

Name	Time	Method
OQ45 outcome questionnaire clinical function scale <63<br><br>maps changes in functioning [ OQ45 at Intake, and x 8 weeks treatment endpoint and at follow up, week 16, <br><br><br>];QOL administered at Intake, and at week 8 and again at followup week 16. <br><br>[ Time points are intake, week 4, week 8 treatment endpoint, and week 16 follow up assessment. <br>. ]