Enrolling by InvitationN/Aketamine

Ketamine Safety and Tolerability in Psychiatric Inpatient Care (KetGD)

Sponsored by Medical University of Gdansk

NCT ID
NCT05565352
Target Enrollment
140 participants
Start Date
2022-09-01
Est. Completion
2029-12-31

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

Major Depressive DisorderPost Traumatic Stress DisorderObsessive-Compulsive DisorderSomatoform DisordersAnxiety DisordersDissociative Disorder

Interventions

  • Ketamine Hydrochloride

Eligibility

Age:18 Years - 90 Years
Healthy Volunteers:No
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

Study Locations (1)

Department of Psychiatry, Medical University of Gdańsk
Gdansk, Poland

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source

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