The Kite Trial: Examining the Effectiveness of Ketamine for Adults with Bipolar Depression

*This study is ongoing, date on last data collection expected 17/09/2027. Data will be available to request following publication of the primary outcome paper, for an indefinite time.

This dataset contains de identified clinical, demographic, treatment, safety, and outcome data from a multicentre, randomised, double blind, active controlled Phase 3 trial evaluating the effectiveness of low dose subcutaneous ketamine compared with midazolam in adults with bipolar depression. Data were collected during a 3 week randomised controlled phase and a subsequent open label extension, with repeated assessments of depressive symptoms, anxiety, suicidality, cognition, quality of life, tolerability, adverse events, and cardiorespiratory responses using validated clinician rated and self reported measures. Primary and secondary outcomes include changes in Montgomery-Åsberg Depression Rating Scale scores, remission and response outcomes and safety endpoints.