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

NCT ID: NCT06232291

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-21
• Study Completion Date: 2024-05-24

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.

Conditions

Treatment-Resistant Depression; Major Depressive Disorder

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Perception Neuroscience

INDUSTRY

Sponsor Role: collaborator

Medical University of Gdansk

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of Gdańsk

Gdansk, , Poland

Countries

Poland

References

Wlodarczyk A, Slupski J, Szarmach J, Cubala WJ. Single arketamine in treatment resistant depression: Presentation of 3 cases with regard to sick-leave duration. Asian J Psychiatr. 2024 Jun;96:104016. doi: 10.1016/j.ajp.2024.104016. Epub 2024 Mar 22.

Reference Type: DERIVED

PMID: 38554563 (View on PubMed)

Other Identifiers

NKBBN/12/2023

Identifier Type: -

Identifier Source: org_study_id