The efficacy of mangosteen pericarp fruit extract as an adjunct to second generation antipsychotic medication for the treatment of Schizophrenia.

Not Applicable

Completed

• Conditions: Schizophrenia; Mental Health - Schizophrenia

• Registration Number: ACTRN12611000910909
• Lead Sponsor: James Cook University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in Positive and Negative Syndrome Scale (PANSS)[Baseline; 90 days, 150 days, 180 days];Reduction in Global Assessment of Functioning (GAF)[Baseline, 90 days, 150 days, 180 days]

Secondary Outcome Measures

Name	Time	Method
Reduction in Abnormal Involuntary Movement Scale (AIMS)[Baseline; 90 days; 150 days; 180 days];Reduction in Montgomery-Asberg Depression Rating Scale[Baseline; 90 days; 150 days; 180 days];Reduction in Liverpool University neuroleptic Side Effect rating Scale (LUNSERS)[Baseline; 90 days; 150 days; 180 days];Reduction in Clinical Global Impression Scale for Severity (CGI-S)[Baseline; 90 days; 150 days; 180 days];Reduction in Self-Rated Life Satisfaction Scale (SRLS)[Baseline; 90 days; 150 days; 180 days]