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

Major Depressive Disorder Clinical Trial

— KetGD  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05565352
• Other study ID #: NKBBN/172-447/2022
• Status: Enrolling by invitation
• Start date: September 1, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: November 2022
• Source: Medical University of Gdansk
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 140
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Conversion Disorder
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Dissociative Disorder
• Dissociative Disorders
• Major Depressive Disorder
• Obsessive-Compulsive Disorder
• Post Traumatic Stress Disorder
• Somatoform Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Ketamine 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.

Locations

Country	Name	City	State
Poland	Department of Psychiatry, Medical University of Gdansk	Gdansk

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline through week 5
Primary	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).	Baseline through week 5
Primary	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	Baseline through week 5
Primary	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.	Baseline through week 5
Primary	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	Baseline through week 5
Primary	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	Baseline through week 5
Primary	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	Baseline through week 5
Primary	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	Baseline through week 5
Secondary	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).	Baseline through week 5
Secondary	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.	Baseline through week 5
Secondary	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	Baseline through week 5
Secondary	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.	Baseline through week 5
Secondary	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.	Baseline through week 5