Enrolling by invitationN/A

Ketamine Safety and Tolerability in Psychiatric Inpatient Care (KetGD)

NCT05565352 · KetGD · Medical University of Gdansk

Closed to entry

Status

Not accepting participants

Not applicable

Phase

140

Target enrolment

Study sites

Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Incidence of adverse events assessed by Clinical-Administered Dissociative Symptoms Scale (CADSS)
Measured over Baseline through week 5
Incidence of adverse events assessed by 4-items positive symptoms subscale of Brief Psychiatric Rating Scale (BPRS)
Measured over Baseline through week 5
Incidence of adverse events assessed by body temperature (oral measurements)
Measured over Baseline through week 5
Incidence of adverse events assessed by blood pressure
Measured over Baseline through week 5
Incidence of adverse events assessed by respiration rate
Measured over Baseline through week 5
Incidence of adverse events assessed by pulse
Measured over Baseline through week 5
Incidence of adverse events assessed by blood oxygen saturation
Measured over Baseline through week 5
Incidence of adverse events assessed by weight
Measured over Baseline through week 5

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 90 Years

Ages

All

Sex

Not accepted

Healthy volunteers

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

Where

1 study site

Facility	City	Region	Country
Department of Psychiatry, Medical University of Gdańsk	Gdansk	—	Poland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05565352 on ClinicalTrials.gov →

Last updated in the registry 2025-04-02. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Ketamine

Indication

All 3 trials from Medical University of Gdansk →