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

January 22, 2024 updated by: Medical University of Gdansk
An observational-comparative study, without interfering with the treatment, based on an operationalized interview.

Study Overview

Status

Enrolling by invitation

Conditions

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 Type

Observational

Enrollment (Estimated)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Gdańsk, Poland, 80-214
        • Medical University of Gdansk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients participating in the PCN-101-21 study from March 4, 2022, on site.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety record post IMP exposure.
Time Frame: 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.
Single psychometric assessment is performed along with a structured interview covering a period of 12 months after participation in the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Gdansk

Collaborators

Perception Neuroscience

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2023

Primary Completion (Actual)

October 13, 2023

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKBBN/12/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

data repository at site, available on request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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