Ketamine Safety and Tolerability in Psychiatric Inpatient Care (KetGD)

NCT05565352 | Enrolling By Invitation DMC

• 1 other identifier: NKBBN/172-447/2022
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Post Traumatic Stress Disorder; Obsessive-Compulsive Disorder; Somatoform Disorders; Anxiety Disorders; Dissociative Disorder

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• Change in severity of depression symptoms assessed by Montgomery-Asberg Depression Rating Scale (MADRS)

  Baseline through week 5

• Change in severity of symptoms assessed by Clinical Global Impression-Severity Scale (CGI-S)

  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 mania symptoms assessed by Young Mania Rating Scale (YMRS)

  Baseline through week 5

Study Arms (7)

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.

Drug: Ketamine Hydrochloride

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.

Drug: Ketamine Hydrochloride

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.

Drug: Ketamine Hydrochloride

Somatoform Disorder

Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Somatoform Disorder as determined by a psychiatrist.

Drug: Ketamine Hydrochloride

Anxiety Disorder

Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Anxiety Disorder as determined by a psychiatrist.

Drug: Ketamine Hydrochloride

Dissociative Disorder

Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Dissociative Disorder as determined by a psychiatrist.

Drug: Ketamine Hydrochloride

Bipolar Disorder

Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Bipolar Disorder as determined by a psychiatrist.

Drug: Ketamine Hydrochloride

Interventions

Ketamine Hydrochloride DRUG

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.

Anxiety Disorder; Bipolar Disorder; Dissociative Disorder; Major Depressive Disorder; Obsessive Compulsive Disorder; Post traumatic Stress Disorder; Somatoform Disorder

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients are referred to the tertiary-reference unit for mood disorders, anxiety disorders, obsessive-compulsive disorder, somatoform disorder, post-traumatic stress disorder, and dissociative disorder

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Department of Psychiatry, Medical University of Gdańsk

Gdansk, 80-952, Poland

Location

Related Publications (4)

• 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.

  PMID: 34733182 BACKGROUND

• 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.

  PMID: 34421299 BACKGROUND

• 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.

  PMID: 34046159 BACKGROUND

• Kachlik Z, Cubala WJ, Walaszek M, Pastuszak M, Pastuszak K, Kwasny A. Nonresponse to Ketamine in Treatment-Resistant Bipolar Depression. Neuropsychopharmacol Rep. 2025 Sep;45(3):e70038. doi: 10.1002/npr2.70038.

  PMID: 40879542 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Stress Disorders, Post-Traumatic; Obsessive-Compulsive Disorder; Somatoform Disorders; Anxiety Disorders; Dissociative Disorders

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 4, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

PL (1)