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

This observational cohort study (n=140) aims to assess the safety and tolerability of ketamine treatment in adult patients suffering from various mental health conditions, including major depressive disorder (MDD), post-traumatic stress disorder (PTSD), obsessive-compulsive disorder (OCD), and others.

Conducted by the Medical University of Gdańsk in Poland, the study will enroll an estimated 140 participants aged 18 to 90 years. Patients will receive ketamine treatment via different routes, including intravenous infusion, intranasal spray, and oral administration, over a period of four weeks.

The primary outcome measures include assessing the incidence of adverse events using various scales and physiological measurements, such as the Clinical-Administered Dissociative Symptoms Scale and body temperature. Secondary outcome measures will evaluate changes in depression severity, global impression, suicidal ideation, and mania symptoms. The study commenced in September 2022 and is estimated to be completed by December 2027.

Topic Depression PTSD Obsessive-Compulsive Disorder
Compound Ketamine
Country Poland
Visit trial
Status Enrolling by invitation
Results Published No
Start date 01 September 2022
End date 31 December 2027
Phase Not Applicable
Design Open
Type Observational
Generation First
Participants 140
Sex All
Age 18- 90
Therapy No

Trial Details

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.

Trial Number NCT05565352

Sponsors & Collaborators

Medical University of Gdansk
The Medical University of Gdańsk is the largest medical academic institution in northern Poland.

Data attribution

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