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The efficacy of mangosteen pericarp fruit extract for the treatment of schizophrenia.

The efficacy of adjunctive Garcinia mangostana Linn. (mangosteen) pericarp for the treatment of schizophrenia: A 24-week double blind randomised placebo controlled trial

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000859482
Acronym
MANGO SZ/CADENCE-M
Enrollment
150
Registered
2016-06-30
Start date
2016-07-28
Completion date
2018-08-02
Last updated
2020-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

There is evidence of anomalies in redox biology in schizophrenia; (i) the presence of oxidative stress (where the levels of antioxidants are decreased or the levels of free radicals are increased to a point that is damaging to the function of the cell, increasing inflammation) particularly implicating the glutathione system ; (ii) changes in oxidative status with treatment; and (iii) evidence that other glutathione and redox active agents have therapeutic value. Garcinia mangostana Linn, known colloquially as mangosteen, is a tropical evergreen fruit tree originating from Indonesia. Its rind or pericarp contains an exudate containing a large number of bioactive compounds called xanthones that have robust effects on the glutathione system and many other pathways germane to schizophrenia. Motivated by the results of the first pilot randomised, double blind placebo trial of adjunctive Garcinia mangostana Linn for the treatment of schizophrenia we speculate that this research may uncover a new class of agents for the treatment of the disorder, and uncover novel pathophysiological pathways. The trial involves 150 participants aged 18 years or older with a DSM-V diagnosis of schizophrenia or schizoaffective disorder. Participants referred to the trial will have an initial face–to-face screening interview. All randomised participants will receive two 500mg mangosteen pericarp capsules once a day to a total dose of 1000mg daily or placebo, in addition to treatment as usual, for 24 weeks. Assessment will occur at regular 4 weekly intervals throughout the 24 weeks and 1 month after completion of the study. The primary outcome will be the change in schiaophrenia symptom severity using the PANSS total scale at the end of the 24-week treatment phase. The secondary outcomes will include changes in depressive symptoms, quality of life, functioning and life satisfaction which will be measured using the PANSS subscales, Q-LES-Q scale, GAF, LIFE-RIFT, PGI and Cogstate. Blood biomarkers will also be analysed. Blood samples will be obtained at baseline and week 24. Blood will be analysed for relevant markers based on preclinical evidence including markers of antioxidant defence, oxidative stress and markers of inflammation. The research will have immediate and direct translational benefits. The safety and tolerability of Garcinia mangostana Linn, its affordability and accessibility and that the general public are accepting of plant-derived compounds, raise its attraction as a potential therapeutic agent.

Interventions

Total daily dose of 1000mg of Garcinia mangostana L. (mangosteen dried fruit pericarp encapsulated in gelatine capsules): 500mg 2 capsules once a day with food. Duration of treatment: 24 weeks Participants will be instructed to return unused medication which will be calculated and documented to determine medication adherence.

Sponsors

University Hospital-Barwon Health
Lead SponsorHospital

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 No maximum
Healthy volunteers
No

Inclusion criteria

1. Being 18 years or older 2. Have a DSM-V diagnosis of schizophrenia or schizoaffective disorder. 3. Score greater than or equal to 54 on the PANSS total score or have a CGI-S score of greater than or equal to 3. 4. Participants currently under therapy for schizophrenia or schizoaffective disorder will need to have been on that primary therapy for at least four weeks prior to randomization. 5. Have the capacity to consent to the study and comply with the procedures. 6. Be using effective contraception if female, sexually active and childbearing age. 7. Be able to speak, read, write and understand English language. 8. Participants will be required to nominate a current treating physician and will not be eligible to enter the study until one is identified.

Exclusion criteria

1. Participants with a known or suspected active systemic medical disorder. 2. Individuals who are pregnant or lactating. 3. Participants currently enrolled in any other intervention study. 4. Individuals who are intolerant, allergic to or have had an anaphylactic reaction to any of the components of the preparation. 5. Inability to comply with either the requirements of informed consent or treatment protocol.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 15, 2026