Clinical TrialSafety & Risk ManagementKetamineKetamineKetamineEnrolling by invitation

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

Observational prospective cohort (n=140) collecting real-world safety and tolerability data on ketamine treatment (IV, intranasal, oral) in adult psychiatric inpatients with a range of diagnoses including MDD, PTSD, OCD and others.

Target Enrollment
140 participants
Study Type
Phase NA observational
Design
Non-randomized

Detailed Description

This prospective observational registry collects systematic real-world data on ketamine administration in a tertiary inpatient psychiatry service to evaluate safety, tolerability and patient-reported outcomes across diverse clinical presentations.

Treatments include slow IV infusions (0.5 mg/kg over 40 minutes), intranasal spray, and oral solution (2.0–2.5 mg/kg), administered twice weekly for 4 weeks; adverse events, vitals and longer-term outcomes are documented to inform clinical practice.

Study Protocol

Preparation

sessions

Dosing

8 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Ketamine treatment

experimental

Real-world ketamine treatment delivered via IV infusion, intranasal spray, or oral solution across diagnostic cohorts in an inpatient tertiary centre.

Interventions

  • Ketamine0.5 mg/kg
    via IV• twice weekly• 8 doses total

    Slow IV infusion 0.5 mg/kg over 40 minutes, twice weekly for 4 weeks (8 sessions).

  • Ketamine
    via Other• twice weekly• 8 doses total

    Intranasal ketamine spray twice weekly for 4 weeks (dose not specified).

  • Ketamine2 - 2.5 mg/kg
    via Oral• twice weekly• 8 doses total

    Oral solution 2.0–2.5 mg/kg twice weekly for 4 weeks.

Participants

Ages
18 – 90
Sexes
Male & Female

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

Study Details

Locations

Department of Psychiatry, Medical University of Gdańsk — Gdansk, Poland

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