What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Arm 1, 2, 3 device interventions, Arm 2 Interventions, or Arm 1, 2, 3 drug Interventions. The registry lists allocation as randomized. Background: Most drugs that treat mood disorders take a long time to work.
They plan to enroll about 70 people at Bethesda. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.
Official title (unrewritten)
The Mechanism of Action Underlying Ketamine's Antidepressant Effects: An Investigation of the AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression
Interventions: Arm 1, 2, 3 device interventions, Arm 2 Interventions, Arm 1, 2, 3 drug Interventions, Arm 1 and 2 Interventions
Primary outcome (registry wording): Acute Antidepressant Efficacy: Change from baseline Montgomery Asberg Depression Rating Scale (MADRS) score post ketamine infusion