This Phase II randomised, quadruple-blind, placebo-controlled trial (n=200) will assess the safety and efficacy of intranasal SLS-002 (ketamine, 78mg) for post-traumatic stress disorder (PTSD) in active-duty service members and veterans.
Adaptive platform, Phase II, randomized study comparing intranasal SLS-002 (78 mg per administration) to placebo over a 12-week treatment period in participants with PTSD.
Dosing schedule: twice weekly for the first 8 weeks, then once weekly for Weeks 9–12 (total 20 administrations); primary analyses compare intervention vs pooled placebo control within the master adaptive platform.
Outcome and safety assessments follow the Master Protocol (NCT05422612) with a 30-day screening period and 4-week safety follow-up after treatment.
Intranasal SLS-002 (ketamine) administered on a 12-week schedule.
Intranasal — one spray per nostril (78 mg) per administration.
Matching intranasal placebo with identical dosing schedule.
Matching intranasal placebo; one spray per nostril per administration.