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

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).

The study comprised three phases: screening (up to 2 weeks), In-Clinic Treatment (including double-blind treatment), and post-treatment follow-up. Adult subjects with TRD were randomly allocated to three arms of the study. PCN-101 and placebo were administered intravenously.

Primary outcome measures included changes in the Montgomery Asberg Depression Rating Scale (MADRS), while secondary measures encompassed various psychological and physiological parameters.

The study began on February 1, 2022, and concluded on November 10, 2022, with a total enrollment of 102 participants. It was sponsored by Perception Neuroscience and conducted across multiple locations in the United States, Germany, and Poland.

Topic Treatment-Resistant Depression Depression
Compound Placebo
Country United States of America Poland Germany
Visit trial
Status Completed
Results Published No
Start date 01 February 2022
End date 10 November 2022
Phase Phase II
Design Blinded
Type Interventional
Generation Second
Participants 102
Sex All
Age 18- 65
Therapy No

Trial Details

This is a double-blind, randomized, placebo-controlled, multicenter study comprised of 3 phases:screening (up to 2 weeks [Day -15 to Day -2]), In-Clinic Treatment (Day -1 to Day 2; including double-blind treatment [Day 1]), and post-treatment follow-up (7 and 14 days after infusion on Days 8 and 15, respectively). A total of 93 adult subjects with TRD will be randomly allocated in equal cohorts of 31 subjects/arm to the 3 arms of the study in a blinded manner.

Trial Number NCT05414422

Sponsors & Collaborators

Perception Neuroscience
Perception Neuroscience is a subsidiary of atai that is developing arketamine therapy for neuropsychiatric diseases.

Data attribution

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