None listed
Conditions
Brief summary
Mangosteen pericarp has potential to act as a tolerable and adjunct treatment option for schizophrenia, however a clinical trial is required to establish efficacy.
Interventions
Garcinia mangostana L. which is mangosteen dried fruit pericarp encapsulated in gelatine capsules to be taken as two 500mg capsules, once a day (total 1000mg/day) with food, for the duration of 180 days.
Sponsors
James Cook 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 65 Years
Healthy volunteers
No
Inclusion criteria
1. Meet DSM-IV-TR criterion for schizophrenia 2. Have current symptoms measured by PANSS score of over 54 or at least two items in the positive or negative items being greater than 2 or have a CGI-S score greater than 2 at baseline 3. Capacity to consent 4. Be stable on current medication regime for the past month 5. Be utilising effective contraception if sexually active and of childbearing age 6. Be aged 18-65 years on day of induction 7. Be an outpatient currently prescribed a second generation antipsychotic medication 8. Speak sufficient english so as not to require an interpreter 9. Reside within a 100 kilometre radius of the Cairns, Grafton Street post office in Far North Queensland, Australia.
Exclusion criteria
1. Persons with a major comorbid medical illness that will restrict completion of the trial 2. Persons with a current high risk of aggression 3. Persons regularly taking up to 10 cups green tea on a daily basis 4. Persons regularly taking at least 1000mg/day vitamin E supplements, however multivitamins are acceptable 5. Persons with an allergy to mangosteen or rice flour 6. Persons unable to comply with informed consent requirements or treatment protocol
Outcome results
None listed