Clinical trial NCT05565352: Ketamine Safety and Tolerability in Psychiatric Inpatient Care (KetGD)
Official title: Ketamine Treatment Safety and Tolerability in Psychiatric Inpatient Care Delivered at Depatment of Psychiatry, Medical University of Gdańsk, Poland
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Major Depressive Disorder
Post Traumatic Stress Disorder
Obsessive-Compulsive Disorder
Somatoform Disorders
Anxiety Disorders
Dissociative Disorder
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients are referred to the tertiary-reference unit for mood disorders, anxiety disorders, obsessive-compulsive disorder, somatoform disorder, post-traumatic stress disorder, and dissociative disorder

Brief 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.


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

Primary outcomes:
measure: Incidence of adverse events assessed by Clinical-Administered Dissociative Symptoms Scale (CADSS)
timeFrame: Baseline through week 5
measure: Incidence of adverse events assessed by 4-items positive symptoms subscale of Brief Psychiatric Rating Scale (BPRS)
timeFrame: Baseline through week 5
measure: Incidence of adverse events assessed by body temperature (oral measurements)
timeFrame: Baseline through week 5
measure: Incidence of adverse events assessed by blood pressure
timeFrame: Baseline through week 5
measure: Incidence of adverse events assessed by respiration rate
timeFrame: Baseline through week 5
measure: Incidence of adverse events assessed by pulse
timeFrame: Baseline through week 5
measure: Incidence of adverse events assessed by blood oxygen saturation
timeFrame: Baseline through week 5
measure: Incidence of adverse events assessed by weight
timeFrame: Baseline through week 5
Secondary outcomes:
measure: Change in severity of depression symptoms assessed by Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline through week 5
measure: Change in severity of symptoms assessed by Clinical Global Impression-Severity Scale (CGI-S)
timeFrame: Baseline through week 5
measure: Change in severity of symptoms assessed by Clinical Global Impression - Improvement Scale (CGI-I)
timeFrame: Baseline through week 5
measure: Change in severity of symptoms assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline through week 5
measure: Change in severity of mania symptoms assessed by Young Mania Rating Scale (YMRS)
timeFrame: Baseline through week 5
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Department of Psychiatry, Medical University of Gdańsk
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.