Efficacy of adjunctive Garcinia mangostana Linn (mangosteen) pericarp for bipolar depression: study protocol for a proof-of-concept trial

Abstract

Objective:Bipolar depression is characterized by neurobiological features including perturbed oxidative biology, reduction in antioxidant levels, and a concomitant rise in oxidative stress markers. Bipolar depression manifests systemic inflammation, mitochondrial dysfunction, and changes in brain growth factors. The depressive phase of the disorder is the most common and responds the least to conventional treatments. Garcinia mangostana Linn, commonly known as mangosteen, is a tropical fruit. The pericarp’s properties may reduce oxidative stress and inflammation and improve neurogenesis, making mangosteen pericarp a promising add-on therapy for bipolar depression.Methods:Participants will receive 24 weeks of either 1,000 mg mangosteen pericarp or placebo per day, in addition to their usual treatment. The primary outcome is change in severity of mood symptoms, measured using the Montgomery-Åsberg Depression Rating Scale (MADRS), over the treatment phase. Secondary outcomes include global psychopathology, quality of life, functioning, substance use, cognition, safety, biological data, and cost-effectiveness. A follow-up interview will be conducted 4 weeks post-treatment.Conclusion:The findings of this study may have implications for improving treatment outcomes for those with bipolar disorder and may contribute to our understanding of the pathophysiology of bipolar depression.Clinical trial registration:Australian and New Zealand Clinical Trial Registry, ACTRN12616000028404.

Adjunctive Garcinia mangostana Linn. (Mangosteen) Pericarp for Schizophrenia: A 24-Week Double-blind, Randomized, Placebo Controlled Efficacy Trial: Péricarpe d’appoint Garcinia mangostana Linn (mangoustan) pour la schizophrénie : un essai d’efficacité de 24 semaines, à double insu, randomisé et contrôlé par placebo

“…As such, we currently have a clinical trial running investigating mangosteen pericarp for bipolar depression. 44 In the interests of improving the clinical outcomes of people living with schizophrenia, it is essential that high quality clinical trials of safe therapeutic agents continue to improve the health and psychosocial outcomes for people with psychotic disorders.…”

Mangosteen Pericarp and Its Bioactive Xanthones: Potential Therapeutic Value in Alzheimer’s Disease, Parkinson’s Disease, and Depression with Pharmacokinetic and Safety Profiles

“…These positive results may initiate further research of MP for the treatments of depression and other psychiatric disorders with depression. In fact, one RCT (Trial registry ID: ACTRN12616000028404) is currently in progress investigating the efficacy of adjunctive MP for bipolar depression [ 103 ].…”

The Therapeutic Potential of Mangosteen Pericarp as an Adjunctive Therapy for Bipolar Disorder and Schizophrenia

“…There is a need to demonstrate these findings from animal models in human studies. There are currently two studies directly trialing the effect of mangosteen pericarp on schizophrenia ( 118 ) (Trial registry ID: ACTRN12616000859482) and bipolar depression ( 119 ) (Trial registry ID: ACTRN12616000028404), both in adult populations.…”