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

M

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

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.

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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