The Kite Trial: Ketamine vs. Midazolam for Bipolar Depression

A multicentre, randomised, double-blind, active-controlled Phase 3 trial evaluating low-dose subcutaneous ketamine compared with midazolam in adults with bipolar depression. Data includes clinical, demographic, treatment, safety, and outcome measures collected during a 3-week randomised phase and an open-label extension. The dataset is provided by MACH HeSANDA and will be available for request after the primary outcome paper is published.

Use Cases

• Compare treatment efficacy based on changes in Montgomery-Åsberg Depression Rating Scale scores.
• Analyze safety and tolerability profiles based on adverse event and cardiorespiratory response data.
• Model remission and response outcomes using repeated assessments of depressive symptoms and suicidality.
• Study longitudinal patient outcomes based on data from the randomised controlled phase and open-label extension.

Strengths

• Data originates from a Phase 3 randomised controlled trial, a gold-standard study design.
• Includes repeated assessments using validated clinician-rated and self-reported measures.
• Covers multiple data domains: clinical, demographic, treatment, safety, and outcomes.

Limitations

• Row count is unknown, which may limit suitability assessment.
• Column-level documentation is absent; field semantics must be inferred after download.
• Data access is restricted until after primary outcome publication, with an expected final collection date of 17/09/2027.

Provenance

Source

MACH HeSANDA

Collection Method

Collected during a multicentre, randomised, double-blind, active-controlled Phase 3 clinical trial.

Time Range

Data collection is ongoing, with a last expected collection date of 17/09/2027.

Freshness

Last updated 2026-04-28 23:34:56; freshness should be verified as the study is ongoing.