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NCT05565352: KetGD
Ketamine Safety and Tolerability in Psychiatric Inpatient Care (KetGD)
trial testing Ketamine Hydrochloride in Major Depressive Disorder in 140 participants. Enrolling by invitation.
31 December 2029
Quick facts
| Lead sponsor | Medical University of Gdansk |
|---|---|
| Status | ENROLLING BY INVITATION |
| Study type | OBSERVATIONAL |
| Enrollment | 140 |
| Start date | 1 September 2022 |
| Primary completion | 31 December 2029 |
| Estimated completion | 31 December 2029 |
| Sites | 1 location across Poland |
Drugs / interventions tested
- Ketamine Hydrochloride — full drug profile →
Conditions studied
- Major Depressive Disorder — all drugs for Major Depressive Disorder →
- Post Traumatic Stress Disorder — all drugs for Post Traumatic Stress Disorder →
- Obsessive-Compulsive Disorder — all drugs for Obsessive-Compulsive Disorder →
- Somatoform Disorders — all drugs for Somatoform Disorders →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
Ketamine dosing formula in treatment-resistant bipolar depression.
Kwaśny A, Jerzy Cubała W, Wilkowska A. · · 2025 · PMID 41262415 · DOI 10.1177/20451253251392817 -
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:
- PubMed search for NCT05565352
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ketamine Hydrochloride
Trials testing the same drug.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05565352 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medical University of Gdansk
- Last refreshed: 2 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05565352.
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