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NCT05565352: KetGD

Ketamine Safety and Tolerability in Psychiatric Inpatient Care (KetGD)

ENROLLING BY INVITATION Last updated 2 April 2025
What this trial tests

trial testing Ketamine Hydrochloride in Major Depressive Disorder in 140 participants. Enrolling by invitation.

Timeline
1 September 2022
Primary endpoint
31 December 2029
31 December 2029

Quick facts

Lead sponsorMedical University of Gdansk
StatusENROLLING BY INVITATION
Study typeOBSERVATIONAL
Enrollment140
Start date1 September 2022
Primary completion31 December 2029
Estimated completion31 December 2029
Sites1 location across Poland

Drugs / interventions tested

Conditions studied

Sponsor

Medical University of Gdansk

Who can join

Adults 18 to 90, any sex, with Major Depressive Disorder or Post Traumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Ketamine for bipolar depression: an updated systematic review.
    Fancy F, Haikazian S, Johnson DE, Chen-Li DCJ, et al · · 2023 · cited 15× · PMID 37771417 · DOI 10.1177/20451253231202723
  2. Hereditary Patterns and Genetic Associations in Obsessive-Compulsive Disorder (OCD): Neuropsychiatric Insights, Genetic Influences, and Treatment Perspectives.
    Dhiman A, Mehan S, Khan Z, Tiwari A, et al · · 2025 · cited 4× · PMID 39219434 · DOI 10.2174/0115665232316708240828063527
  3. Residual Depressive Symptoms in Treatment-Resistant Bipolar Depression Following Short-Term Ketamine Administration.
    Pastuszak M, Cubała WJ, Kwaśny A. · · 2024 · cited 3× · PMID 39269606 · DOI 10.1007/s40801-024-00453-y
  4. Nonresponse to Ketamine in Treatment-Resistant Bipolar Depression.
    Kachlik Z, Cubała WJ, Walaszek M, Pastuszak M, et al · · 2025 · cited 2× · PMID 40879542 · DOI 10.1002/npr2.70038
  5. Clinical correlates of anhedonia non-response to ketamine in treatment-resistant depression.
    Walaszek M, Cubała WJ, Kachlik Z, Pastuszak M, et al · · 2026 · PMID 41956221 · DOI 10.1016/j.jad.2026.121762
  6. Anhedonia nonresponse to short-term ketamine administration for treatment-resistant bipolar depression.
    Kachlik Z, Cubała WJ, Walaszek M, Pastuszak M, et al · · 2026 · PMID 41631109 · DOI 10.1177/20451253251412629
  7. Ketamine dosing formula in treatment-resistant bipolar depression.
    Kwaśny A, Jerzy Cubała W, Wilkowska A. · · 2025 · PMID 41262415 · DOI 10.1177/20451253251392817
  8. Non-response to short-term ketamine use for treatment-resistant depression.
    Walaszek M, Cubała WJ, Kachlik Z, Pastuszak M, et al · · 2025 · PMID 40305000 · DOI 10.1007/s43440-025-00730-9

Verify or expand the search:

Other trials of Ketamine Hydrochloride

Trials testing the same drug.

Other recruiting trials for Major Depressive Disorder

Currently open trials in the same condition.

Other Medical University of Gdansk trials

Trials by the same sponsor.

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Data sources for this page

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