Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000910909
Ethics application status
Approved
Date submitted
7/07/2011
Date registered
25/08/2011
Date last updated
1/05/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy of mangosteen pericarp fruit extract as an adjunct to second generation antipsychotic medication for the treatment of Schizophrenia.
Scientific title
The efficacy of Garcinia mangostana L. (mangosteen) pericarp as an adjunct with second generation antipsychotics for the treatment of Schizophrenia: A double- blind, randomized, placebo controlled trial.
Secondary ID [1] 262611 0
No secondary ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 258741 0
Condition category
Condition code
Mental Health 258892 258892 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 266956 0
Treatment: Other
Comparator / control treatment
Rice flour weighted gelatine capsules to be taken as two 500mg capsules, once a day (total 1000mg/day) with food, for the duration of 180 days.
Control group
Placebo

Outcomes
Primary outcome [1] 269189 0
Reduction in Positive and Negative Syndrome Scale (PANSS)
Timepoint [1] 269189 0
Baseline; 90 days, 150 days, 180 days
Primary outcome [2] 294960 0
Reduction in Global Assessment of Functioning (GAF)
Timepoint [2] 294960 0
Baseline, 90 days, 150 days, 180 days
Secondary outcome [1] 268510 0
Reduction in Abnormal Involuntary Movement Scale (AIMS)
Timepoint [1] 268510 0
Baseline; 90 days; 150 days; 180 days
Secondary outcome [2] 279092 0
Reduction in Montgomery-Asberg Depression Rating Scale
Timepoint [2] 279092 0
Baseline; 90 days; 150 days; 180 days
Secondary outcome [3] 279093 0
Reduction in Liverpool University neuroleptic Side Effect rating Scale (LUNSERS)
Timepoint [3] 279093 0
Baseline; 90 days; 150 days; 180 days
Secondary outcome [4] 279094 0
Reduction in Clinical Global Impression Scale for Severity (CGI-S)
Timepoint [4] 279094 0
Baseline; 90 days; 150 days; 180 days
Secondary outcome [5] 279095 0
Reduction in Self-Rated Life Satisfaction Scale (SRLS)
Timepoint [5] 279095 0
Baseline; 90 days; 150 days; 180 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited through an advertisement which will refer potential participants to their treating physician for screening. Physicians will be asked to screen persons for DSM-IV-TR criterion for schizophrenia; current aggression risk; ability to consent. Physicians will be provided with a phone number to contact investigators. Investigators will contact the potential participant for a prelimninary interview. Informed consent will be obtained and pregnancy testing conducted prior to inclusion in the trial. Participants will be allocated a study number for trial identification purposes.

The capsules for the intervention will be manufactured by a compounding pharmacy and transported to the clinical trials pharmacist in opaque jars. The clinical trials pharmacist will be responsible for conducting the study blinding and central randomization, labelling for clinical trials and sealing of containers. The clinical trial pharmacist will distribute the allocated intervention to the investigator for delivery to the potential participant simutaneously with induction completion and in sequencial order.

The investigator who is conducting the trial induction and the participant, will be blinded to the type of intervention until after data analysis, unless there is an urgent medical contraindication.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The generation of the sequence allocation will be by computer tables. The sequence will be kept in a locked cupboard by the clinical pharmacist until data analysis is completed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
The study is designed as a pilot study to test for relief of symptoms and reduction of unwanted effects of the medication.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Mixed model repeated methods

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2011
Actual
21/11/2011
Date of last participant enrolment
Anticipated
21/10/2012
Actual
21/10/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 267421 0
University
Name [1] 267421 0
James Cook University
Country [1] 267421 0
Australia
Funding source category [2] 267422 0
Commercial sector/Industry
Name [2] 267422 0
Mangosteen Dietary Supplements
Country [2] 267422 0
Australia
Funding source category [3] 291198 0
Charities/Societies/Foundations
Name [3] 291198 0
Far North Queensland Hospital Foundation
Country [3] 291198 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
James Cook University Cairns,
Mcgregor Road,
Smithfield,
Qld 4870.
Country
Australia
Secondary sponsor category [1] 266473 0
None
Name [1] 266473 0
Address [1] 266473 0
Country [1] 266473 0
Other collaborator category [1] 251706 0
Other Collaborative groups
Name [1] 251706 0
Orygen Research Centre
Address [1] 251706 0
Department of Psychiatry,
The University of Melbourne,
35 Poplar Road,
Parkville,
Vic 3052.
Country [1] 251706 0
Australia
Other collaborator category [2] 278454 0
Individual
Name [2] 278454 0
Associate Professor Susan Cotton,
Address [2] 278454 0
Orygen Youth Mental Health Institute,
35 Poplar Road, Parkville, Vic 3052.
Country [2] 278454 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260140 0
Cairns and Hinterland Health Service District Human Research Ethics Committee
Ethics committee address [1] 260140 0
Ethics committee country [1] 260140 0
Australia
Date submitted for ethics approval [1] 260140 0
Approval date [1] 260140 0
16/06/2011
Ethics approval number [1] 260140 0
HREC/11/QCH/47 - 732

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31971 0
Dr Wendy Laupu
Address 31971 0
School of Nursing, Midwifery and Nutrition,
James Cook University (Cairns Campus),
McGregor Road,
Smithfield,
Qld 4870
Country 31971 0
Australia
Phone 31971 0
+61 0413 632 907
Fax 31971 0
Email 31971 0
[email protected]
Contact person for public queries
Name 15218 0
Kim Usher
Address 15218 0
School of Nursing, Midwifery and Nutrition,
James Cook University,
Cairns Campus,
McGregor Road,
Smithfield,
Qld 4870
Country 15218 0
Australia
Phone 15218 0
+61 7 40421048
Fax 15218 0
Email 15218 0
[email protected]
Contact person for scientific queries
Name 6146 0
Wendy Laupu
Address 6146 0
James Cook University,
Cairns Campus,
McGregor Road,
Smithfield,
Cairns, Qld 4870.
Country 6146 0
Australia
Phone 6146 0
+61 413 632 907
Fax 6146 0
Email 6146 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.