Clinical TrialTreatment-Resistant Depression (TRD)Completed

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

This observational study (n=3) aims to observe the safety and tolerability of arketamine or placebo in patients with treatment-resistant depression (TRD) over a period of 12 months following their participation in a previous clinical trial (PCN-101-21).

Target Enrollment
3 participants
Study Type
Phase NA observational
Design
Non-randomized

Detailed Description

Observational, comparative, retrospective study collecting quarterly (3, 6, 9, 12 months ±4 weeks) effectiveness and safety observations from patients who participated in the PCN-101-21 trial without altering their clinical care.

Background: reports suggest potential antidepressant effects of R-ketamine; this study aims to assess longer-term tolerability, safety and functional outcomes after intravenous R-ketamine or placebo exposure in a prior phase 2 trial.

Outcomes include disease exacerbations, hospitalisations, changes to psychotropic treatment, and functional impairment requiring social support; the study uses non-probability sampling and is retrospective.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Expressing informed consent to participate in the study and earlier participation in the PCN-101-21 study on site.

Exclusion Criteria

  • Exclusion Criteria:
  • Informed consent withdrawal.

Study Details

Locations

Medical University of Gdańsk — Gdansk, Poland

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