Ketamine Safety and Tolerability in Psychiatric Inpatient Care (KetGD)

Medical University of Gdansk

Status: Invitation-only

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

Treatments: Drug: Ketamine Hydrochloride

Study type: Observational

Funder types: Other

Identifiers

NCT05565352

NKBBN/172-447/2022

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

140 participants in 7 patient groups

Major Depressive Disorder

Description:

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

Treatment:

Drug: Ketamine Hydrochloride

Obsessive Compulsive Disorder

Description:

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

Treatment:

Drug: Ketamine Hydrochloride

Post traumatic Stress Disorder

Description:

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

Treatment:

Drug: Ketamine Hydrochloride

Somatoform Disorder

Description:

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

Treatment:

Drug: Ketamine Hydrochloride

Anxiety Disorder

Description:

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

Treatment:

Drug: Ketamine Hydrochloride

Dissociative Disorder

Description:

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

Treatment:

Drug: Ketamine Hydrochloride

Bipolar Disorder

Description:

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

Treatment:

Drug: Ketamine Hydrochloride