Treatment With Psilocybin for Chronic Neuropathic Pain and Depression (TRANSCEND) (TRANSCEND)
This open-label, Phase II trial (n=16) will assess the feasibility, tolerability, and preliminary efficacy of psilocybin (25 mg) therapy for adults with chronic neuropathic pain and treatment-resistant depression (TRD).
Details
Single-group, open-label Phase II study administering a single oral 25 mg dose of psilocybin with supportive psychotherapy to adults with chronic neuropathic pain and co-morbid treatment-resistant depression to assess feasibility, tolerability, and preliminary efficacy.
Outcomes include safety and tolerability, pain measures (LANSS, PROMIS, pain intensity), and depression severity (HamD-17) with screening, baseline, acute and follow-up assessments.
Participants must be able to taper antidepressant/antipsychotic medication prior to dosing, be medically stable with adequate renal function, and have no personal or first-degree family history of psychotic disorders.