The Taiora Trial: A community-based randomized placebo-controlled trial evaluating micronutrients for emotion dysregulation in teenagers experiencing mood problems

Not Applicable

Recruiting

• Conditions: Emotion dysregulation; Mental Health - Other mental health disorders

• Registration Number: ACTRN12621000399897
• Lead Sponsor: Professor Julia Rucklidge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-09
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

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

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified