Observation of Ketamine Treatment Safety and Tolerability in Adult Psychiatry Clinic Medical University of Gdańsk Inpatients

• Conditions: Major Depressive Disorder; Obsessive-Compulsive Disorder; Dissociative Disorder; Post Traumatic Stress Disorder; Somatoform Disorders; Anxiety Disorders
• Interventions: Drug: Ketamine Hydrochloride

• Registration Number: NCT05565352
• Lead Sponsor: Medical University of Gdansk

Brief Summary

Adult Psychiatry Clinic Medical University of Gdańsk (MUG) is a healthcare facility that provides ketamine treatment to adult patients suffering from mental health conditions. The Clinic especially treats individuals suffering from treatment-resistant disorders, like - mood disorders, anxiety disorders, obsessive-compulsive and related disorders, trauma and stressor-related disorders, somatic symptom and related disorders, and dissociative disorders. Herein, this naturalistic observation aims to look at the safety and tolerability of ketamine treatment to further develop the understanding of ketamine in the use of psychiatry.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2022-09-29
• Study First Submitted QC: 2022-09-29
• Study First Posted: 2022-10-04
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-14
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 140

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obsessive Compulsive Disorder	Ketamine Hydrochloride	Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Obsessive Compulsive Disorder (OCD) as determined by a psychiatrist.
Somatoform Disorder	Ketamine Hydrochloride	Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Somatoform Disorder as determined by a psychiatrist.
Dissociative Disorder	Ketamine Hydrochloride	Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Dissociative Disorder as determined by a psychiatrist.
Anxiety Disorder	Ketamine Hydrochloride	Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Anxiety Disorder as determined by a psychiatrist.
Major Depressive Disorder	Ketamine Hydrochloride	Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Major Depressive Disorder (MDD), as determined by a psychiatrist.
Bipolar Disorder	Ketamine Hydrochloride	Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Bipolar Disorder as determined by a psychiatrist.
Post traumatic Stress Disorder	Ketamine Hydrochloride	Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Post-Traumatic Stress Disorder (PTSD) as determined by a psychiatrist.

Primary Outcome Measures

Name	Time	Method
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 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).
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 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 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 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 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

Secondary Outcome Measures

Name	Time	Method
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).
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 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 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.

Trial Locations

Locations (1)

Department of Psychiatry, Medical University of Gdańsk; 🇵🇱 Gdańsk, Poland