The efficacy of micronutrients as a treatment for emotional dysregulation in teenagers experiencing mood difficulties/problems: A community randomized placebo-controlled trial

Professor Julia Rucklidge0 个研究点目标入组 150 人开始时间: 2021年4月9日最近更新: 2023年12月12日

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•1) between 12 and 17 years, 2) regular access to the internet/phone, 3) living in New Zealand, 4) considered reliable and compliant with protocol (including ingestion of as many as 12 capsules/day with food), 5) be presenting to their GP or school counsellor with functionally impairing emotional dysregulation which cannot be better accounted for by a medical condition or parental identified as showing disabling emotions that are interfering with their ability to function, 6) sufficient ability to read and write English in order to complete questionnaires, 7) be attending primary or high school, and 8) receive a CGI-S rating of at least 4 (moderately ill) on screening and a minimum score of 10 on the Emotion Dysregulation Inventory or 3 on the Affective Reactivity Index.

•1) The main strict contraindications are metabolic conditions such as Wilson’s disease (copper), haemochromatosis (iron), phenylketonuira (phenylalanine) and trimethylaminuria (choline), 2) Known neurological disorders involving brain or other central function (e.g., previously diagnosed 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) pregnant or breastfeeding, and 4) Any medications with primarily central nervous system activity, including psychotropic medication (e.g. SSRIs, tricyclics, benzodiazepines). Participants must have been off these medications for a minimum of four weeks prior to the trial. Participants will not be encouraged to come off a medication in order to participate.

发起方

Professor Julia Rucklidge