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.
Study Type
OBSERVATIONAL
Enrollment
140
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) Ketamine will be given in intranasal spray twice weekly over a period of 4 weeks Ketamine will be given orally (solution 2.0mg/kg, 2.5mg/kg) twice weekly over a period of 4 weeks.
Department of Psychiatry, Medical University of Gdańsk
Gdansk, Poland
Incidence of adverse events assessed by Clinical-Administered Dissociative Symptoms Scale (CADSS)
Incidence of adverse events will be assessed by Clinician-Administered Dissociative Symptoms Scale (change from baseline to each measure). Higher values represent a worse severity, but not necessarily outcome. The Clinical-Administered Dissociative Symptoms Scale has 23-items based on dissociative symptoms during the assessment. Each item is scored 0 (normal) to 4 (severe symptoms) with overall score ranges from 0 (normal) to 92 (severe symptoms). Total number of assessments:18 times
Time frame: Baseline through week 5
Incidence of adverse events assessed by 4-items positive symptoms subscale of Brief Psychiatric Rating Scale (BPRS)
Incidence of adverse events will be assessed by 4-items positive symptoms subscale of Brief Psychiatric Rating Scale (change from baseline to each measure). Higher values represent a worse severity but not necessarily outcome. The 4-item positive symptoms subscale of Brief Psychiatric Rating Scale has 4-items based on conceptual disorganization, suspiciousness, hallucination and unusual thought content. Each item is scored 0 (normal) to 6 (severe symptoms) with overall score ranges from 0 (normal) to 24 (severe symptoms).
Time frame: Baseline through week 5
Incidence of adverse events assessed by body temperature (oral measurements)
Incidence of adverse events assessed by body temperature (oral measurement) in Celsius degree - change from baseline to each measure. A normal range is from 36.2 to 38.0 Celsius degrees; measurements beyond those ranges are clinically significant. The total number of measurements: 44 times
Time frame: Baseline through week 5
Incidence of adverse events assessed by blood pressure
Incidence of adverse events assessed by blood pressure (after the participant has rested for at least 5 minutes) in mmHg - change from baseline to each measure. A normal range for systolic blood pressure is from 90 to 140 mmHg, for diastolic blood pressure is from 50 to 90 mmHg; measurements beyond those ranges are clinically significant.
Time frame: Baseline through week 5
Incidence of adverse events assessed by respiration rate
Incidence of adverse events assessed by respiration rate in a breath number per minute - change from baseline to each measure. A normal range for respiration is from 12 to 16 breaths per minute; measurements beyond those ranges are clinically significant. The total number of measurements: 44 times
Time frame: Baseline through week 5
Incidence of adverse events assessed by pulse
Incidence of adverse events assessed by pulse (beats per minute \[bpm\]) - change from baseline to each measure. A normal range for pulse is from 60 to 90 bpm; measurements beyond those ranges are clinically significant. The total number of measurements: 44 times
Time frame: Baseline through week 5
Incidence of adverse events assessed by blood oxygen saturation
Incidence of adverse events assessed by blood oxygen saturation in percentage - change from baseline to each measure. A normal range for blood oxygen saturation is from 95 to 100 percentage; measurements under 95% are clinically significant. The total number of measurements: 44 times
Time frame: Baseline through week 5
Incidence of adverse events assessed by weight
Incidence of adverse events assessed by weight in kilograms- change from baseline to each measure. Gain weight for 7% baseline weight is clinically significant. Total numbers of assessments: 2. Weight and height will be combined to report BMI in kg/m\^2
Time frame: Baseline through week 5
Change in severity of depression symptoms assessed by Montgomery-Asberg Depression Rating Scale (MADRS)
Change in severity of depression symptoms from baseline to each measure. Higher values represent a worse severity, but not necessarily outcome. The MADRS has 10-items which are based on mood symptoms over the past 7 days. Each item is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).
Time frame: Baseline through week 5
Change in severity of symptoms assessed by Clinical Global Impression-Severity Scale (CGI-S)
CGI-S is a seven-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. CGI-S score starting from 1-not at all ending at 7-extremely severe.
Time frame: Baseline through week 5
Change in severity of symptoms assessed by Clinical Global Impression - Improvement Scale (CGI-I)
CGI-I is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.CGI-I score starting from 1-very much-improved ending at 7-very much worse
Time frame: Baseline through week 5
Change in severity of symptoms assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS is an assessment tool that evaluates suicidal ideation and behavior.
Time frame: Baseline through week 5
Change in severity of mania symptoms assessed by Young Mania Rating Scale (YMRS)
YMRS is an 11-item interviewer-rated scale used to evaluate manic symptoms at baseline and over time. The total scale score ranges from 0 to 60, where higher scores indicate more severe mania.
Time frame: Baseline through week 5
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