Effect of a nutritional supplement on attention and mood in adults with Attention-Deficit/Hyperactivity Disorder

Phase 1

Completed

• Conditions: Attention-Deficit/Hyperactivity Disorder; Mood instability; Mental Health - Other mental health disorders; Mental Health - Depression

• Registration Number: ACTRN12609000202268
• Lead Sponsor: Julia Rucklidge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1.Participants are older than 18 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 and show signs of some mood instability.

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oral antibiotic in the previous 6 weeks (if an antibiotic was started during the course of the trial, that patient was withdrawn from the study), 10) any type of nutritional or herbal supplement, known to have a centrally-acting effect (patients who had been taking supplements such as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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Conners Adult ADHD Rating Scale which assesses ADHD symptoms including inattention, hyperactivity and impulsivity[baseline, 8 weeks];Montgomery Asberg Depression Rating Scale[baseline, 8 weeks];The Young Mania Rating Scale which assesses symptoms of heightened and elevated mood such as mania[baseline, 8 weeks]

Secondary Outcome Measures

Name	Time	Method
The Range of Impaired Functioning Tool (LIFE-RIFT) to measure quality of life[baseline, 8 weeks];Depression, Anxiety, and Stress Scale[baseline, 8 weeks];Novaco Anger Scale which assesses anger management[baseline, 8 weeks];The Clinical Global Impressions Severity (CGI-S) and Improvement (CGI-I) Scales which are clinician rated questions assessing the severity of the illness (e.g., mild, moderate, severe) and any changes that have occurred since the last visit (e.g. no change, much improved, very much improved)[baseline, 8 weeks]