Observation of Safety and Tolerability Within 1 Year of the Use of R-ketamine /​ Placebo in Drug-resistant Depression

This observational study (n=3) aims to observe the safety and tolerability of arketamine or placebo in patients with treatment-resistant depression (TRD) over a period of 12 months following their participation in a previous clinical trial (PCN-101-21).

The study, conducted by the Medical University of Gdańsk, involves retrospective analysis without interfering with diagnostics, treatment, or rehabilitation. Patients who previously participated in the PCN-101-21 trial are eligible for inclusion, provided they provide informed consent.

The primary outcome measure is the safety record post-R-ketamine exposure, focusing on events such as exacerbation of symptoms, hospitalization, changes in treatment, and functional disorders requiring social support.

The study, which started in April 2023 and had its primary completion in October 2023, is estimated to be completed by April 2024. It is conducted at the Medical University of Gdańsk, Poland.

Trial Details

Patients with treatment-resistant depression constitute a significant proportion (even 30%) of patients diagnosed with major depressive disorder (MDD. Since 2014, there have been reports of a potential antidepressant effect of the R-ketamine stereoisomer. At the UCK Department of Psychiatry, a phase 2 clinical trial (2a) has been conducted since 2022 with the use of R-ketamine in the form of an intravenous solution, administered by an infusion pump to patients with drug-resistant depression (sponsor Perception Neuroscience, Inc., protocol PCN-101-21, NCT05414422). The available data from studies indicate a potential treatment-transformative effect of the drug, but do not provide comprehensive information on the long-term effects of treatment in terms of effectiveness, tolerability, and safety of R-ketamine use. The study is cognitive and comparative study, without interfering with the diagnostics, treatment, and rehabilitation. It aims to collect effectiveness and safety observations within 12 months of participation in the PCN-101-21 study, at quarterly intervals (3, 6, 9, 12 months, +/- 4 weeks), with particular emphasis on exacerbations of the underlying disease, hospitalization, correction of psychotropic treatment or functional impairment requiring support from social security authorities. The study does not involve additional diagnostic, therapeutic or rehabilitation goals and is a retrospective analysis performed during a single visit.

Trial Number NCT06232291

Data attribution

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