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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Source Study

Purpose

Treatment

Phase

Phase 2

Funding

University,Deakin University, IMPACT SRC Seed Funding Grant

Scientific enquiries

A/Prof Olivia Dean

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 interv ....
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Key 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 potent ....
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Key Exclusion Criteria

1. Participants with a known or suspected active systemic medical disorder, 2. Individuals who are pregnant or lactating (participants will be requested to conduct a urine pregnancy test if sexually active and of child-bearing age), 3. Participants currently enrolled in any other intervention study will be excluded, 4. Individuals who are intolerant, allergic to or have had an anaphylactic reaction to any components of the preparation, 5. Inability to comply with either the requirements of infor ....
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Can healthy volunteers participate?

No

 

Population

Sample Size    152

Min. age    18 Years

Max. age    No limit

Sex    Both males and females

Condition category    Bipolar depression

Condition code    Mental Health

Intervention

Intervention code Treatment: Drugs

1000mg/day of oral (2 capsules, once a day) of adjunctive Garcinia Mangostana Linn. (mangosteen) pericarp will be trialled against placebo for 24 weeks to determine the efficacy of mangosteen pericarp for the treatment of bipolar depression. Adherence will be monitored by participants returning all bottles of investigational product, including any unused capsules.

Comparison

Control group Placebo

Placebo (inactive starch)

Outcomes

Outcome: Change in severity of mood symptoms, measured using the Montgomery Åsberg Depression Rating Scale (MADRS).
Timepoint: Conducted at all trial visits - Baseline (week 0) and every four weeks after that (week 4, 8, 12, 16, 20, 24)

Study Protocol: Study protocol
Data Dictionary: Study protocol

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/

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au