Ketamine for Adults with Bipolar Depression (the Kite Trial): A Randomised, Double-blind, Midazolam-controlled, Multicentre Clinical Trial

The University of Melbourne0 个研究点目标入组 98 人开始时间: 2024年6月26日最近更新: 2024年7月8日

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•Consent and Capacity: Eligible participants must be able to provide written informed consent, demonstrating adequate intellectual capacity and fluency in English.
•Age Requirement: Participants must be aged 18 years or older at the time of informed consent. Diagnosis: Participants must meet the DSM-5 criteria for either bipolar I or bipolar II disorder, currently experiencing a Major Depressive Episode, confirmed using the Structured Clinical Interview for DSM-5 (SCID-5).
•Depression Severity: Participants must present with moderate-to-severe depression (as indicated by MADRS score greater than or equal to 20).
•Stable Pharmacotherapy: Participants must be receiving stable pharmacotherapy treatment with one or more mood stabilising medications, which can include lithium, anti-convulsants, and atypical antipsychotics, for at least 28 days prior to the first treatment visit (Day 1) and must remain stable throughout the trial (unless changes are clinically indicated);
•Reproductive Health Requirements: People of Childbearing Potential (POCBP) must have a negative pregnancy test, not be breastfeeding, and use effective contraception throughout the study. Additionally, abstention from egg or sperm donation during and following the study is required, with specific time frames set for each.

•Excluded Diagnoses: Participants should not meet DSM-5 criteria for current major depressive episodes with mixed features, rapid cycling bipolar disorder, schizoaffective disorder, or schizophrenia.
•Compliance Issues: Participants with severe disturbances that prevent compliance with the study requirements or informed consent are excluded.
•Medical Contradictions: Those with unstable medical conditions or contraindications to ketamine or midazolam use, according to product information forms, are not eligible.
•Substance Use: Any history of ketamine use disorder or substance use disorder of at least moderate severity within the past 6 months excludes participation.
•Concurrent Trial Participation: Participation in another clinical trial from the first day of this trial until the first follow-up visit (Day 39) disqualifies prospective participants.

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