A micronutrient intervention for adults experiencing symptoms of anxiety and depression.

Not Applicable

Completed

• Conditions: Anxiety; Depression; Mental Health - Anxiety; Mental Health - Depression

• Registration Number: ACTRN12617001647325
• Lead Sponsor: Professor Julia Rucklidge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-21
• Study Completion: 2022-05-31
• Last Update Posted: 24 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1) between 18 and 65 years, 2) regular access to the internet, 3) considered reliable and compliant with the protocol (including the ingestion of as many as 12 capsules/day with food), 4) be proficient in comprehension of written and spoken English language and 5) and be presenting to their general practitioner (GP) with functionally impairing anxiety or depressive symptoms which cannot be better accounted for by a medical condition.

Exclusion Criteria

1) The main strict contraindications are metabolic conditions such as Wilson’s disease (copper), haemochromatosis (iron), phenylketonuira (phenylalanine) and trimethylaminuria (choline). 2) Neurological disorders involving brain or other central function (e.g., intellectual disability, autism spectrum disorder, epilepsy, MS, narcolepsy) or other major psychiatric condition requiring hospitalization (e.g. significant mood disorder with associated suicidality, substance dependence or psychosis), 3) Any serious medical condition, 4) Any patient known to be allergic to the ingredients of the intervention, 5) Any other medication with primarily central nervous system activity, including psychotropic medication (e.g. SSRIs, tricyclics, benzodiazepines). Participants must have been off of these medications for a minimum of four weeks prior to the trial. Participants are not encouraged to come off of a medication in order to participate in the trial. 6) Women who are pregnant or breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Generalised Anxiety Disorder 7-Question Scale (GAD-7)[Baseline (week 0), weekly during RCT (week 1 through 10) and open label (week 11 through 20), end of RCT (week 10), end of open label (week 20), 1 year follow up (week 52). <br><br>End of RCT (week 10) is considered the primary endpoint];Patient Health Questionnaire - 9 (PHQ-9)[Baseline (week 0), weekly during RCT (week 1 through 10) and open label (week 11 through 20), end of RCT (week 10), end of open label (week 20), 1 year follow up (week 52). <br><br>End of RCT (week 10) is considered the primary endpoint ];Clinical Global Inventory (CGI). [End of RCT (week 10), end of open label (week 20), 1 year follow up (week 52). End of RCT (week 10) is considered the primary endpoint. ]