Ketamine Safety and Tolerability in Psychiatric Inpatient Care (KetGD)

Официальное название

Ketamine Treatment Safety and Tolerability in Psychiatric Inpatient Care Delivered at Depatment of Psychiatry, Medical University of Gdańsk, Poland

Обзор

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.

Вмешательства

• Препарат 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

Первичные конечные точки

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

Вторичные конечные точки (5)

• Change in severity of depression symptoms assessed by Montgomery-Asberg Depression Rating Scale (MADRS) [Срок оценки: Baseline through week 5]
• Change in severity of symptoms assessed by Clinical Global Impression-Severity Scale (CGI-S) [Срок оценки: Baseline through week 5]
• Change in severity of symptoms assessed by Clinical Global Impression - Improvement Scale (CGI-I) [Срок оценки: Baseline through week 5]
• Change in severity of symptoms assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) [Срок оценки: Baseline through week 5]
• Change in severity of mania symptoms assessed by Young Mania Rating Scale (YMRS) [Срок оценки: Baseline through week 5]

Критерии участия

Критерии включения

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

Критерии исключения

• Pregnancy and lactation
• Hypersensitivity to ketamine
• Uncontrolled hypertension
• Other uncontrolled somatic diseases that may impact safety per the investigator's judgment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Польша · 1 центр

• Department of Psychiatry, Medical University of Gdańsk — Gdansk

Публикации

• 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

Идентификаторы

NCT: NCT05565352 · NKBBN/172-447/2022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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