Observation of Safety and Tolerability Within 1 Year of the Use of R-ketamine / Placebo in Drug-resistant Depression
1 other identifier
observational
3
1 country
1
Brief Summary
An observational-comparative study, without interfering with the treatment, based on an operationalized interview.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 21, 2023
CompletedFirst Submitted
Initial submission to the registry
January 22, 2024
CompletedFirst Posted
Study publicly available on registry
January 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 24, 2024
CompletedMay 29, 2024
May 1, 2024
1.1 years
January 22, 2024
May 25, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Safety record post IMP exposure.
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.
Eligibility Criteria
Patients participating in the PCN-101-21 study from March 4, 2022, on site.
You may qualify if:
- Expressing informed consent to participate in the study and earlier participation in the PCN-101-21 study on site.
You may not qualify if:
- Informed consent withdrawal.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical University of Gdansklead
- Perception Neurosciencecollaborator
Study Sites (1)
Medical University of Gdańsk
Gdansk, 80-214, Poland
Related Publications (1)
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.
PMID: 38554563DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2024
First Posted
January 30, 2024
Study Start
April 21, 2023
Primary Completion
May 24, 2024
Study Completion
May 24, 2024
Last Updated
May 29, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
data repository at site, available on request