Anxiety Disorders, Dissociative Disorder, Major Depressive Disorder, Obsessive-Compulsive Disorder, Post Traumatic Stress Disorder, Somatoform Disorders
Conditions
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.
Interventions
DRUGKetamine 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) 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.
Sponsors
Medical University of Gdansk
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events assessed by weight | 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 body temperature (oral measurements) | 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 blood pressure | 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 | 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 pulse | 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 |
| Incidence of adverse events assessed by blood oxygen saturation | 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 Clinical-Administered Dissociative Symptoms Scale (CADSS) | 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 4-items positive symptoms subscale of Brief Psychiatric Rating Scale (BPRS) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in severity of symptoms assessed by Clinical Global Impression-Severity Scale (CGI-S) | Baseline through week 5 | 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. |
| Change in severity of symptoms assessed by Clinical Global Impression - Improvement Scale (CGI-I) | Baseline through week 5 | 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 |
| Change in severity of symptoms assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline through week 5 | C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. |
| Change in severity of mania symptoms assessed by Young Mania Rating Scale (YMRS) | Baseline through week 5 | 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. |
| Change in severity of depression symptoms assessed by Montgomery-Asberg Depression Rating Scale (MADRS) | Baseline through week 5 | 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). |
Countries
Poland
Outcome results
None listed