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A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of PCN-101 in TRD

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This double-blind, randomized, placebo-controlled trial (n=93) aimed to assess the safety and efficacy of IV ketamine (PCN-101) in treating Treatment-Resistant Depression (TRD).

Details

Multicentre, randomized, triple-blind, parallel-group Phase II study comparing single IV infusions of R-ketamine (PCN-101) 30 mg, PCN-101 60 mg, and placebo in adults with treatment-resistant depression.

Design comprised screening, in-clinic treatment (double-blind infusion on Day 1) and follow-up visits on Days 8 and 15 to assess safety and depressive symptoms; primary purpose treatment.

Topics:Treatment-Resistant Depression (TRD)

Registry

Registry linkNCT05414422