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

Completed

• Conditions: Treatment-Resistant Depression; Major Depressive Disorder

• Registration Number: NCT06232291
• Lead Sponsor: Medical University of Gdansk

Brief Summary

An observational-comparative study, without interfering with the treatment, based on an operationalized interview.

Detailed Description

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.

Study Timeline

• Study Start: 2023-04-21
• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-30
• Status Verified: 2024-05
• Primary Completion: 2024-05-24
• Study Completion: 2024-05-24
• Last Update Submitted: 2024-05-25
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Expressing informed consent to participate in the study and earlier participation in the PCN-101-21 study on site.

Exclusion Criteria

Informed consent withdrawal.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety record post IMP exposure.	Single psychometric assessment is performed along with a structured interview covering a period of 12 months after participation in the study.	time to event and its nature: exacerbation of symptoms, hospitalization, change of treatment, functional disorders requiring social support.

Trial Locations

Locations (1)

Medical University of Gdańsk; 🇵🇱 Gdańsk, Poland