Observation of Safety and Tolerability Within 1 Year of the Use of R-ketamine / Placebo in Drug-resistant Depression
Launched by MEDICAL UNIVERSITY OF GDANSK · Jan 22, 2024
Trial Information
Current as of July 31, 2025
Completed
Keywords
ClinConnect Summary
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 st...
Gender
ALL
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.
About Medical University Of Gdansk
The Medical University of Gdańsk is a leading institution in healthcare education and research located in Gdańsk, Poland. Renowned for its commitment to advancing medical knowledge and improving patient outcomes, the university actively engages in innovative clinical trials across various medical disciplines. With a focus on multidisciplinary collaboration and state-of-the-art facilities, the Medical University of Gdańsk fosters an environment conducive to groundbreaking research and the development of novel therapeutic interventions. Its dedicated team of researchers, clinicians, and academic professionals is dedicated to enhancing healthcare through rigorous scientific inquiry and community engagement.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Gdańsk, , Poland
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported