None listed
Conditions
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.
Interventions
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.
Sponsors
Barwon Health
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. 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.
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 informed consent or the treatment protocol.
Outcome results
None listed