The Kite trial is investigating whether low-dose ketamine is effective in reducing depressive symptoms in adults with bipolar depression.
About this study
We are inviting adults with bipolar depression to take part in this novel randomised controlled trial (RCT).
Eligible participants will be randomised to receive 6 treatments (2 treatments per week for 3 weeks) of either low-dose ketamine or low-dose midazolam (an active control treatment). There is a 1 in 2 (50%) chance that participants will receive ketamine treatment during the RCT phase.
Participants who complete the RCT phase may be eligible to take part in the open label extension (OLE) phase. The OLE phase involves a further 6 low-dose ketamine treatments (2 treatments per week for 3 weeks).
Anticipated enrolment close date: June 2027
Who can take part
This trial might be right for you if you:
- Are aged 18 years and over
- Have been diagnosed with bipolar disorder I or II and are currently experiencing a depressive episode
- Have been treated with a stable dose of one or more mood stabilising medications for at least 28 days prior to the first treatment
- Have no history of schizophrenia, schizoaffective disorder, or ketamine use disorder
- Have not had any other substance use disorder of at least moderate severity within the past six months
Please note that other eligibility criteria also apply.
What's involved
Participation includes:
- Attending 8 visits at the RMH during the RCT phase (including 6 treatment visits that are scheduled twice a week for 3 weeks)
- Participants who complete the open label extension phase attend a further 6 treatment visits at RMH (twice a week for 3 weeks)
- Participants who do not complete the open label extension phase have a follow-up visit three weeks after the completion of the RCT phase
- All participants have a final follow-up visit 3 months after their first treatment
- Treatment is administered via subcutaneous (under the skin) injection into the abdomen (stomach)
- Completion of interviews and questionnaires
- Safety blood tests and assessment of blood pressure, weight and height
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.