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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06232291
• Other study ID #: NKBBN/12/2023
• Status: Enrolling by invitation
• Start date: April 21, 2023
• Est. completion date: April 2024

Study information

• Verified date: January 2024
• Source: Medical University of Gdansk
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3
• Est. completion date: April 2024
• Est. primary completion date: October 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Major Depressive Disorder
• Treatment-Resistant Depression

Locations

Country	Name	City	State
Poland	Medical University of Gdansk	Gdansk

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Gdansk	Perception Neuroscience

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.