Data

The efficacy of adjunctive Garcinia mangostana linn (mangosteen) pericarp for bipolar depression: A 24-week double-blind, randomised, placebo controlled trial.

Barwon Health

Dataset description

This 24-week double-blind, randomized, placebo controlled efficacy trial evaluated the efficacy of adjunctive mangosteen pericarp, compared to placebo, in the treatment of schizophrenia. People diagnosed with schizophrenia or schizoaffective disorder (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), recruited across 2 sites (Brisbane and Victoria, Australia), were randomized to receive 24 weeks of adjunctive mangosteen pericarp (1,000 mg/day) or matched placebo. The primary outcome measure was the Positive and Negative Symptom Scale total score. Secondary outcomes included positive and negative symptoms, general psychopathology, clinical global severity and improvement, participant reported overall improvement, depressive symptoms, functioning, quality of life, and safety data at 24 and 28 weeks (4 weeks post discontinuation). Data were collected from July 2016 to February 2019.
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Related Study

The efficacy of adjunctive Garcinia mangostana linn (mangosteen) pericarp for bipolar depression: A 24-week double-blind, randomised, placebo controlled trial.

Brief Summary

Aims The primary aim of this study is to investigate the efficacy of adjunctive mangosteen pericarp 1000mg/day for the treatment of bipolar depression using a 24 Week randomised, placebo controlled trial. The primary outcome measure will be the change in severity of mood symptoms, measured using the Montgomery Asberg Depression Rating Scale (MADRS). Secondary outcomes include global psychopathology, substance use, functioning, quality of life, and safety and tolerability data. A follow-up interview will be conducted 4 weeks posttreatment to determine any outcomes following cessation of the trial agent. Method We plan to recruit a total of 150 participants aged 18+years with moderate to severe bipolar depression (having a DSM5 diagnosis of bipolar I or II or bipolar disorder not elsewhere classified (NEC), determined using the Structured Clinical Interview for DSM Disorders 5 (SCID5), currently be in a major depressive episode on SCID5, and meeting criteria of a Montgomery Asberg Depression Rating Scale (MADRS) score of greater than or equal to 20. Participants will attend a screening visit to ascertain suitability and once randomized they will receive a month’s supply of either 1000mg/day of mangosteen or matched placebo to be taken in addition to their treatment as usual. Participants take two capsules per day. Participants will visit the study site at weeks 4, 8, 12, 16, 20 24 and 28 (4 weeks posttreatment discontinuation) where a battery of validated outcome measures will be administered by trained research staff. Participants will be asked to discuss their symptoms, side effects and any issues the participant would like to raise regarding the trial. Participants will be notified of which arm of the study they took part in and a summary of results at the completion of the study.

Inclusion Criteria

  • 1. Must be required to meet DSM-5 criteria for bipolar disorder I or II, or bipolar disorder not elsewhere classified (NEC) and be currently be in a major depressive episode on SCID-5-RV 2. Have a current episode of depressive illness with a MADRS score greater than or equal to 20 3. Have capacity to consent to the study and comply with study procedures 4. Any form of therapy must be stable for the last month 5. Using effective contraception if female, sexually active and of child bearing potential 6. Be able to speak, read, write and understand the English language, 7. Participants will be required to nominate a current treating physician and will not be eligible to enter the study until one is identified.

Study Type

  • Interventional

Ethics Approval

Study Protocol: Available
Data Dictionary: Available

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

All participant data will be available following publication of the primary data.

When will data be available?

Data will be available following publication of primary and a priori secondary outcomes. No end date

Available to whom?

Data are potentially available to: * researchers from not-for profit organisations; * commercial organisations; or * other research staff with appropriate Human Research and Ethics Approval; based in any location.

Available for what types of analyses?

Data are potentially available for all types of analysis, both patient-level analyses as well as meta-analyses. All data requests will be considered on a case-by-case basis. Please contact Olivia Dean at Deakin University. https://impact-trials.deakin.edu.au/