This study plas to investigate the feasibility and efficacy of open-label repeated intravenous administration of ketamine and scopolamine combined in this population of severely depressed, treatment-resistant patients. The results from this study could lead to the development of new strategies for the treatment of patients with TRD.
Background reports show ketamine infusions produce acute reductions in depression and suicidal ideation; scopolamine also shows significant antidepressant effects sustained over time.
Randomized, parallel-design study comparing three arms (ketamine+placebo; scopolamine+placebo; ketamine+scopolamine). Treatments given twice weekly for three weeks (six sessions); follow-up assessments every two weeks for three months.
15-minute saline then IV ketamine 0.25 mg/kg over 45 minutes; twice weekly for 3 weeks.
45 min ketamine infusion following 15 min placebo
IV scopolamine 2 µg/kg over 15 minutes then 45-minute saline infusion; twice weekly for 3 weeks.
Scopolamine 2 µg/kg over 15 min (active); saline 45 min as placebo comparator; compound recorded as placeholder reference
IV scopolamine 2 µg/kg over 15 min followed by IV ketamine 0.25 mg/kg over 45 min; twice weekly for 3 weeks.
Scopolamine 2 µg/kg over 15 min (active); compound recorded as placeholder reference
Ketamine 0.25 mg/kg over 45 min