Open-label, single-group proof-of-concept study (n=15 actual) assessing simultaneous administration of oral aspirin (486 mg) + oral ketamine (80 mg) as an adjunct to oral antidepressant therapy in outpatients with treatment-resistant depression.
Prospective open-label, single-group proof-of-concept trial evaluating a proprietary VTS-K formulation (486 mg aspirin + 80 mg ketamine) given as a partially buccal/partially swallowed oral dose to adults with treatment-resistant depression.
Participants attend three visits: two in-person dosing/observation visits (at least two hours observation each) and one remote follow-up. Primary outcome is change in depressive symptoms; safety monitored via vital signs and adverse events.
Study population: medically stable adults (18–89 years) with unipolar treatment-resistant major depressive disorder (MADRS >22) who have failed at least one adequate antidepressant trial.
Proprietary oral formulation of aspirin (486 mg) and ketamine (80 mg) administered as a partially buccal/partially swallowed formulation.
Per-dose contains 486 mg aspirin + 80 mg ketamine (VTS-K).