Ketamine Safety and Tolerability in Psychiatric Inpatient Care (KetGD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketamine Hydrochloride.
- Who it may be relevant to
- Registry conditions: Major Depressive Disorder, Post Traumatic Stress Disorder, Obsessive-Compulsive Disorder, Somatoform Disorders. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Ketamine Treatment Safety and Tolerability in Psychiatric Inpatient Care Delivered at Depatment of Psychiatry, Medical University of Gdańsk, Poland
Overview
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.
Interventions
- 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
Primary outcome measures
- Incidence of adverse events assessed by Clinical-Administered Dissociative Symptoms Scale (CADSS) [Time frame: Baseline through week 5]
- Incidence of adverse events assessed by 4-items positive symptoms subscale of Brief Psychiatric Rating Scale (BPRS) [Time frame: Baseline through week 5]
- Incidence of adverse events assessed by body temperature (oral measurements) [Time frame: Baseline through week 5]
- Incidence of adverse events assessed by blood pressure [Time frame: Baseline through week 5]
- Incidence of adverse events assessed by respiration rate [Time frame: Baseline through week 5]
- Incidence of adverse events assessed by pulse [Time frame: Baseline through week 5]
- Incidence of adverse events assessed by blood oxygen saturation [Time frame: Baseline through week 5]
- Incidence of adverse events assessed by weight [Time frame: Baseline through week 5]
Secondary outcome measures (5)
- Change in severity of depression symptoms assessed by Montgomery-Asberg Depression Rating Scale (MADRS) [Time frame: Baseline through week 5]
- Change in severity of symptoms assessed by Clinical Global Impression-Severity Scale (CGI-S) [Time frame: Baseline through week 5]
- Change in severity of symptoms assessed by Clinical Global Impression - Improvement Scale (CGI-I) [Time frame: Baseline through week 5]
- Change in severity of symptoms assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) [Time frame: Baseline through week 5]
- Change in severity of mania symptoms assessed by Young Mania Rating Scale (YMRS) [Time frame: Baseline through week 5]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Poland · 1 center
- Department of Psychiatry, Medical University of Gdańsk — Gdansk
Publications
- Wilkowska A, Wiglusz MS, Galuszko-Wegielnik M, Wlodarczyk A, Cubala WJ. Antianhedonic Effect of Repeated Ketamine Infusions in Patients With Treatment Resistant Depression. Front Psychiatry. 2021 Oct 18;12:704330. doi: 10.3389/fpsyt.2021.704330. eCollection 2021. PMID 34733182
- Wilkowska A, Wlodarczyk A, Galuszko-Wegielnik M, Wiglusz MS, Cubala WJ. Intravenous Ketamine Infusions in Treatment-Resistant Bipolar Depression: An Open-Label Naturalistic Observational Study. Neuropsychiatr Dis Treat. 2021 Aug 14;17:2637-2646. doi: 10.2147/NDT.S325000. eCollection 2021. PMID 34421299
- Wlodarczyk A, Cubala WJ, Galuszko-Wegielnik M, Szarmach J. Central nervous system-related safety and tolerability of add-on ketamine to antidepressant medication in treatment-resistant depression: focus on the unique safety profile of bipolar depression. Ther Adv Psychopharmacol. 2021 May 19;11:20451253211011021. doi: 10.1177/20451253211011021. eCollection 2021. PMID 34046159
- Kachlik Z, Cubala WJ, Walaszek M, Pastuszak M, Pastuszak K, Kwasny A. Nonresponse to Ketamine in Treatment-Resistant Bipolar Depression. Neuropsychopharmacol Rep. 2025 Sep;45(3):e70038. doi: 10.1002/npr2.70038. PMID 40879542
Identifiers
NCT: NCT05565352 · NKBBN/172-447/2022