Ketamine Treatment Safety and Tolerability in Psychiatric Inpatient Care Delivered at Depatment of Psychiatry, Medical University of Gdańsk, Poland
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Incidence of adverse events assessed by weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Pregnancy and lactation
- •Hypersensitivity to ketamine
- •Uncontrolled hypertension
- •Other uncontrolled somatic diseases that may impact safety per the investigator's judgment
研究组 & 干预措施
Major Depressive Disorder
Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Major Depressive Disorder (MDD), as determined by a psychiatrist.
干预措施: Ketamine Hydrochloride (Drug)
Obsessive Compulsive Disorder
Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Obsessive Compulsive Disorder (OCD) as determined by a psychiatrist.
干预措施: Ketamine Hydrochloride (Drug)
Post traumatic Stress Disorder
Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Post-Traumatic Stress Disorder (PTSD) as determined by a psychiatrist.
干预措施: Ketamine Hydrochloride (Drug)
Somatoform Disorder
Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Somatoform Disorder as determined by a psychiatrist.
干预措施: Ketamine Hydrochloride (Drug)
Anxiety Disorder
Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Anxiety Disorder as determined by a psychiatrist.
干预措施: Ketamine Hydrochloride (Drug)
Dissociative Disorder
Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Dissociative Disorder as determined by a psychiatrist.
干预措施: Ketamine Hydrochloride (Drug)
Bipolar Disorder
Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Bipolar Disorder as determined by a psychiatrist.
干预措施: Ketamine Hydrochloride (Drug)
结局指标
主要结局
Incidence of adverse events assessed by weight
时间窗: Baseline through week 5
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
Incidence of adverse events assessed by 4-items positive symptoms subscale of Brief Psychiatric Rating Scale (BPRS)
时间窗: Baseline through week 5
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).
Incidence of adverse events assessed by blood pressure
时间窗: Baseline through week 5
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.
Incidence of adverse events assessed by respiration rate
时间窗: Baseline through week 5
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
Incidence of adverse events assessed by Clinical-Administered Dissociative Symptoms Scale (CADSS)
时间窗: Baseline through week 5
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
Incidence of adverse events assessed by blood oxygen saturation
时间窗: Baseline through week 5
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
Incidence of adverse events assessed by body temperature (oral measurements)
时间窗: Baseline through week 5
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
Incidence of adverse events assessed by pulse
时间窗: Baseline through week 5
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
次要结局
- Change in severity of depression symptoms assessed by Montgomery-Asberg Depression Rating Scale (MADRS)(Baseline through week 5)
- Change in severity of mania symptoms assessed by Young Mania Rating Scale (YMRS)(Baseline through week 5)
- Change in severity of symptoms assessed by Clinical Global Impression - Improvement Scale (CGI-I)(Baseline through week 5)
- Change in severity of symptoms assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)(Baseline through week 5)
- Change in severity of symptoms assessed by Clinical Global Impression-Severity Scale (CGI-S)(Baseline through week 5)