NCT05565352

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 140 (estimated)
• Sponsor: Medical University of Gdansk · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

• Major Depressive Disorder
• Post Traumatic Stress Disorder
• Obsessive-Compulsive Disorder
• Somatoform Disorders
• Anxiety Disorders
• Dissociative Disorder

Interventions

Type	Name	Description
DRUG	Ketamine Hydrochloride	Ketamine, a N-methyl-D-aspartate (NMDA) receptor antagonist has been used for general anesthesia since the 1970s, however, reports and trials by the end of the twentieth century and onward using subanesthetic doses suggested robust and rapid antidepressant and anti-suicidal effects. Ketamine is available as a 50/50 racemic mixture of enantiomers (S)-ketamine and (R)-ketamine.Ketamine will be infused (slow IV infusions of ketamine (0.5 mg/kg) over 40 minutes) twice weekly over a period of 4 weeks) Ketamine will be given in intranasal spray twice weekly over a period of 4 weeks Ketamine will be given orally (solution 2.0mg/kg, 2.5mg/kg) twice weekly over a period of 4 weeks.

Timeline

• Start date: 2022-09-01
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2022-10-04
• Last updated: 2025-04-02

Locations

1 site across 1 country: Poland