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

Barwon Health0 个研究点目标入组 152 人开始时间: 2016年1月18日最近更新: 2023年10月3日

适应症

试验速览

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•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.

•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.

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