None listed
Conditions
Brief summary
To date, randomized clinical trials have only assessed the efficacy of single-nutrient supplementation in early psychosis. Research in other populations has indicated that combining various nutrients within multi-ingredient ‘nutraceuticals’ can result in greater benefits for mental health than single-nutrient supplementation, and is less likely to cause nutritional imbalances. This project will be the first internationally to assess the feasibility and efficacy of a multi-ingredient nutraceutical for treating young people with early psychosis. The novel formula contains a range of food-derived nutrients including vitamins, minerals, antioxidants and amino-acids. Each of these nutrients, in isolation, have already been indicated as potentially effective adjunct treatments for mental health conditions, perhaps through restoring nutritional deficiencies, and targeting abnormal brain processes implicated in the disorders. We hypothesize that combining these nutrients within a single nutraceutical, and administering this in early illness (when nutrients are most effective), may present a novel adjunctive treatment for improving outcomes of early psychosis. This pilot study will assess the feasibility and effectiveness of a multi-ingredient nutraceutical, designed to act as an adjunctive with standard antipsychotic treatment, in order to improve physical and mental health outcomes in people with early psychosis. Specifically, we will be performing a randomized controlled trial to test the hypothesis that adjunctive treatment with a nutrient-enriched fruit flavoured drink mix can reduce negative symptoms in young people with early psychosis.
Interventions
Intervention: Novel nutritional formula containing a combination of vitamins, minerals and amino-acids; administered as 10g of effervescent fruit-flavoured drink mix, once per day for 12 weeks
Adherence to the intervention will be measured through both self-report and observational measures.
Self Report: a reminder application will be installed on each participant’s mobile phone. This will be set to present a reminder message once per day for 12 weeks, along with a single-touch tick box for p
Intervention: Novel nutritional formula containing a combination of vitamins, minerals and amino-acids; administered as 10g of effervescent fruit-flavoured drink mix, once per day for 12 weeks Adherence to the intervention will be measured through both self-report and observational measures. Self Report: a reminder application will be installed on each participant’s mobile phone. This will be set to present a reminder message once per day for 12 weeks, along with a single-touch tick box for participants to record their adherence. Adherence logs will be saved only to the participants phone, for collection upon 12-week in person visit. However, all participants will be free to decline using the smartphone app without it affecting their participation. Observational: Adherence (as total number of doses) will be corroborated by asking participant to bring their tubs of the nutritional formula to the 6-week and 12-week assessment visits; these will be weighed by the researcher. Participants will be informed that their compliance to the protocol is measured for research purposes only and will have no bearing on their payment or continued participation in the study.
Sponsors
Western Sydney University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
• Currently engaged in Early Intervention in Psychosis mental health services • Aged 18 to 35 years • Sufficient level of spoken English to complete the baseline assessments • Has the capacity to consent to the study and follow its procedures • Within the first 3 years of receiving antipsychotic medication for a psychotic disorder, currently prescribed at a stable dose (as determined by referring clinician) • Report ongoing negative symptoms; defined as scoring at least 3/5 for severity on at least 4 items of the ‘Motivation and Pleasure Scale – Self-Report’
Exclusion criteria
• Changes in antipsychotic medication dose or type within the last 4 weeks • Non-compliance with current antipsychotic medication regime • Current use of specified nutraceuticals above stated thresholds • Taking warfarin or phenytoin • Known or suspected clinically unstable systemic medical disorder (including cancer, organ failure, or serious cardio/cerebrovascular disease) • Pregnancy or breastfeeding • Previous known allergic reactions to any ingredients featured in the formulated product • Currently suicidal (as defined by a score of >1 on item 9 of the BDI-II) • Co-morbid alcohol/substance-use disorder or dependency (as determined by referring clinician)
Outcome results
None listed