This non-randomised trial (n=25) investigates the effects of ketamine on anxiety ratings in patients with anxiety disorders, specifically Generalized Anxiety Disorder (GAD) or Social Phobia (SP).
Phases 1–2 evaluate within-subject ascending single subcutaneous ketamine doses (0.25, 0.5, 1 mg/kg) with ~1 week between doses; Phase 1 open‑label, Phase 2 double‑blind with midazolam active control.
Phase 3 offers maintenance ketamine (1–2× weekly for up to 3 months) to participants achieving ≥50% reduction in anxiety. Outcomes include change in HAM‑A/SSAI/LSAS at predose, 1h, 2h, 24h (primary), 72h and 168h; safety via vital signs and monitoring up to 24h post-dose.
Within-subject ascending single doses of ketamine (0.25→1 mg/kg SC) with ~1 week between doses; responders may enter Phase 3 maintenance.
Subcutaneous (SC) administration; ascending single doses 0.25, 0.5, 1 mg/kg ~1 week apart. Phase 3 maintenance 1–2× weekly up to 3 months for responders (individualised dose).
Double-blind active control (midazolam 0.01 mg/kg SC) used in Phase 2; timing randomized within ascending ketamine doses.
Subcutaneous (SC) active control; administered randomized within ascending ketamine doses in Phase 2.