Ketamine Safety and Tolerability in Psychiatric Inpatient Care (KetGD)
Sponsored by Medical University of Gdansk
About This Study
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.
Conditions Studied
Interventions
- •Ketamine Hydrochloride
Eligibility
View full eligibility criteria
Inclusion Criteria: 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 Exclusion Criteria: * Pregnancy and lactation * Hypersensitivity to ketamine * Uncontrolled hypertension * Other uncontrolled somatic diseases that may impact safety per the investigator's judgment