A Study of a N, N-dimethyltryptamine (DMT) Analog (CYB004) in Participants With Generalized Anxiety Disorder (GAD) With Depressive Symptoms
This double-blind, active-controlled study (n=36) aims to evaluate the preliminary clinical efficacy, safety, tolerability, and pharmacokinetics of CYB004 (DMT) in participants diagnosed with Generalized Anxiety Disorder (GAD) with depressive symptoms.
Details
Proof-of-concept, randomised, double-blind, parallel-group Phase II study evaluating CYB004, a deuterated DMT analog, for treatment of GAD with depressive symptoms; estimated n=36.
Participants receive EMBARK manualised psychotherapy throughout; drug arms compare a full therapeutic dose versus a low (active comparator) dose given in two medicine sessions approximately three weeks apart.
Outcomes include safety, tolerability, pharmacokinetics, and preliminary clinical efficacy measures collected at acute and follow-up timepoints.