utritional interventions for depression: An open label trial for nonresponders to probiotic treatment using a micronutrient formula.

Not Applicable

Completed

• Conditions: Depression; Mental Health - Depression; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12613001067763
• Lead Sponsor: Julia Rucklidge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

Inclusion Criteria

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.

Exclusion Criteria

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 If an antibiotic is begun during the course of the trial, that patient will be withdrawn from the study.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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MADRS score - Montgomery Asberg Depression Rating Scale - clinician<br>rated[Baseline, 8 weeks (end of trial)];iCGI- Improved Clinical Global Improvement Scale - clinician-rated, severity and improvement[Baseline, 8 weeks];QIDS - Quick Inventory of Depressive Symptomatology - patient-rated[Baseline, 4 weeks, 8 weeks (end of trial)]

Secondary Outcome Measures

Name	Time	Method
DASS - depression, anxiety and stress scale[Baseline, 4 weeks, 8 weeks];DAS - Dysfunctional Attitude Scale[Baseline, 4 weeks, 8 weeks];ATQ - automatic thoughts questionnaire[Baseline, 4 weeks, 8 weeks]