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NCT05565352Enrolling by invitation

Ketamine Safety and Tolerability in Psychiatric Inpatient Care (KetGD)

Ketamine Treatment Safety and Tolerability in Psychiatric Inpatient Care Delivered at Depatment of Psychiatry, Medical University of Gdańsk, Poland

Source: ClinicalTrials.gov · Last updated 2 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This observational registry aims to collect real-world data on ketamine use in psychiatric inpatients within a regional tertiary-reference center. The study evaluates the safety and tolerability of ketamine administration in individuals with treatment-resistant mental disorders, characterized by diverse comorbidities, heterogeneous disease courses, and variations in treatment responses based on illness stage and severity with a subset of patients with remitted-recurrent and treatment-resistant or chronic presentations. The registry is designed to systematically document adverse events, side effects, and patient-reported outcomes, providing a comprehensive assessment of both the short- and long-term effects of ketamine in psychopharmacology. By generating real-world evidence, this study shall contribute to a more nuanced understanding of ketamine's risk-benefit profile in clinical practice, particularly in subpopulations that are underrepresented in clinical trials. The findings prioritize the support for the refinement of treatment protocols and enhance patient safety in psychiatric care.

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
140 (estimated)
First submitted
29 Sept 2022
Start date
1 Sept 2022
Primary completion date
31 Dec 2029
Lead sponsor
Medical University of Gdansk
Diseases
Depression
NCT number
NCT05565352

What you commit to

  • Study type: Observational
  • Planned participants: 140
  • From 1 Sept 2022 to the primary completion date, 31 Dec 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Hypersensitivity to ketamine
  • Uncontrolled hypertension
  • Other uncontrolled somatic diseases that may impact safety per the investigator's judgment

Other

  • Pregnancy and lactation

Who the study is looking for

  • Diagnosis as provided by DSM-5 criteria:
  • Major depressive disorder (MDD),
  • Bipolar disorder (BD),
  • Anxiety disorder,
  • Obsessive-compulsive disorder (OCD),
  • Somatoform disorder,
  • Post-traumatic stress disorder (PTSD),
  • Dissociative disorder

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Psychiatry, Medical University of Gdańsk
Coordinator of this site? Confirm its status
GdanskPolandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.