ACTRN12617001647325Completed未知
An investigation examining the effectiveness and safety of a micronutrient intervention on symptoms of depression and anxiety adults: A double blind, randomized, placebo controlled trial.
Professor Julia Rucklidge0 sites150 target enrollmentStarted: December 21, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 150
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (—)
- Sex
- All
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.
Investigators
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