Investigation into the effect of a nutritional supplement on attention and mood in a clinical sample of adults with Attention-Deficit/Hyperactivity Disorder (ADHD): a double blind randomized placebo controlled trial with open label extension.

Julia Rucklidge0 sites80 target enrollmentMay 19, 2009

ConditionsAttention-Deficit/Hyperactivity Disorder Mood instability Mental Health - Other mental health disorders Mental Health - Depression

Overview

Phase: 未知
Intervention: Not specified
Conditions: Attention-Deficit/Hyperactivity Disorder
Sponsor: Julia Rucklidge
Enrollment: 80
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 19, 2009

End Date

June 1, 2013

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Julia Rucklidge

Eligibility Criteria

Inclusion Criteria

•1\.Participants are older than 16 years of age. 2\.Each participant must have a level of understanding sufficient to complete the questionnaires and examinations required by the protocol and be considered reliable and compliant with the protocol (including the ingestion of as many as 15 capsules/day). 3\.Participants must be able to eat at least a snack three times per day, so that the capsules will not be ingested on an empty stomach. 4\.Participants meet criteria for ADHD.

Exclusion Criteria

•1\) neurological disorder involving brain or other central function (e.g., epilepsy, multiple sclerosis (MS), narcolepsy), 2\) any serious medical condition for which major medical interventions was anticipated during the trial, 3\) any patient known to be allergic to the ingredients of the intervention, 4\) pregnancy or breastfeeding (pregnancy testing occurred at baseline and monthly thereafter), 5\) evidence of untreated or unstable thyroid disease (thyroid testing will occur at baseline), 6\) any known abnormality of mineral metabolism (e.g., Wilson’s disease, haemochromatosis), 7\) evidence of substance dependence within the previous month, 8\) any other medication with primarily central nervous system activity, including mood stabilizers (participants must have been off of these medications for a minimum of 4 weeks prior to the trial), 9\) patients were excluded temporarily if they had taken an oral antibiotic in the previous 6 weeks (if an antibiotic was started during the course of the trial, that patient was withdrawn from the study), 10\) any type of nutritional or herbal supplement, known to have a centrally\-acting effect (patients who had been taking supplements such as echinacea, chondroitin, or glucosamine could enter the study if a) they have been taking these agents for at least one month prior to the study, and b) they continued on these agents throughout the study), and 11\) any subject judged clinically to be at serious risk for suicide or violence in the opinion of the researchers.