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Enrolling by Invitation

NCT Number: NCT05565352

Ketamine Safety and Tolerability in Psychiatric Inpatient Care (KetGD)

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.

Enrolling by Invitation

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketamine Hydrochloride

Drug

Ketamine, a N-methyl-D-aspartate (NMDA) receptor antagonist has been used for general anesthesia since the 1970s, however, reports and trials by the end of the twentieth century and onward using subanesthetic doses suggested robust and rapid antidepressant and anti-suicidal effects. Ketamine is available as a 50/50 racemic mixture of enantiomers (S)-ketamine and (R)-ketamine.Ketamine will be infused (slow IV infusions of ketamine (0.5 mg/kg) over 40 minutes) twice weekly over a period of 4 weeks) Ketamine will be given in intranasal spray twice weekly over a period of 4 weeks Ketamine will be given orally (solution 2.0mg/kg, 2.5mg/kg) twice weekly over a period of 4 weeks.

Primary outcomes

  1. Incidence of adverse events assessed by Clinical-Administered Dissociative Symptoms Scale (CADSS)

    Time frame: Baseline through week 5

    Incidence of adverse events will be assessed by Clinician-Administered Dissociative Symptoms Scale (change from baseline to each measure). Higher values represent a worse severity, but not necessarily outcome. The Clinical-Administered Dissociative Symptoms Scale has 23-items based on dissociative symptoms during the assessment. Each item is scored 0 (normal) to 4 (severe symptoms) with overall score ranges from 0 (normal) to 92 (severe symptoms). Total number of assessments:18 times

  2. Incidence of adverse events assessed by 4-items positive symptoms subscale of Brief Psychiatric Rating Scale (BPRS)

    Time frame: Baseline through week 5

    Incidence of adverse events will be assessed by 4-items positive symptoms subscale of Brief Psychiatric Rating Scale (change from baseline to each measure). Higher values represent a worse severity but not necessarily outcome. The 4-item positive symptoms subscale of Brief Psychiatric Rating Scale has 4-items based on conceptual disorganization, suspiciousness, hallucination and unusual thought content. Each item is scored 0 (normal) to 6 (severe symptoms) with overall score ranges from 0 (normal) to 24 (severe symptoms).

  3. Incidence of adverse events assessed by body temperature (oral measurements)

    Time frame: Baseline through week 5

    Incidence of adverse events assessed by body temperature (oral measurement) in Celsius degree - change from baseline to each measure. A normal range is from 36.2 to 38.0 Celsius degrees; measurements beyond those ranges are clinically significant. The total number of measurements: 44 times

  4. Incidence of adverse events assessed by blood pressure

    Time frame: Baseline through week 5

    Incidence of adverse events assessed by blood pressure (after the participant has rested for at least 5 minutes) in mmHg - change from baseline to each measure. A normal range for systolic blood pressure is from 90 to 140 mmHg, for diastolic blood pressure is from 50 to 90 mmHg; measurements beyond those ranges are clinically significant.

  5. Incidence of adverse events assessed by respiration rate

    Time frame: Baseline through week 5

    Incidence of adverse events assessed by respiration rate in a breath number per minute - change from baseline to each measure. A normal range for respiration is from 12 to 16 breaths per minute; measurements beyond those ranges are clinically significant. The total number of measurements: 44 times

  6. Incidence of adverse events assessed by pulse

    Time frame: Baseline through week 5

    Incidence of adverse events assessed by pulse (beats per minute [bpm]) - change from baseline to each measure. A normal range for pulse is from 60 to 90 bpm; measurements beyond those ranges are clinically significant. The total number of measurements: 44 times

  7. Incidence of adverse events assessed by blood oxygen saturation

    Time frame: Baseline through week 5

    Incidence of adverse events assessed by blood oxygen saturation in percentage - change from baseline to each measure. A normal range for blood oxygen saturation is from 95 to 100 percentage; measurements under 95% are clinically significant. The total number of measurements: 44 times

  8. Incidence of adverse events assessed by weight

    Time frame: Baseline through week 5

    Incidence of adverse events assessed by weight in kilograms- change from baseline to each measure. Gain weight for 7% baseline weight is clinically significant. Total numbers of assessments: 2. Weight and height will be combined to report BMI in kg/m^2

Secondary outcomes

  1. Change in severity of depression symptoms assessed by Montgomery-Asberg Depression Rating Scale (MADRS)

    Time frame: Baseline through week 5

    Change in severity of depression symptoms from baseline to each measure. Higher values represent a worse severity, but not necessarily outcome. The MADRS has 10-items which are based on mood symptoms over the past 7 days. Each item is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).

  2. Change in severity of symptoms assessed by Clinical Global Impression-Severity Scale (CGI-S)

    Time frame: Baseline through week 5

    CGI-S is a seven-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. CGI-S score starting from 1-not at all ending at 7-extremely severe.

  3. Change in severity of symptoms assessed by Clinical Global Impression - Improvement Scale (CGI-I)

    Time frame: Baseline through week 5

    CGI-I is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.CGI-I score starting from 1-very much-improved ending at 7-very much worse

  4. Change in severity of symptoms assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: Baseline through week 5

    C-SSRS is an assessment tool that evaluates suicidal ideation and behavior.

  5. Change in severity of mania symptoms assessed by Young Mania Rating Scale (YMRS)

    Time frame: Baseline through week 5

    YMRS is an 11-item interviewer-rated scale used to evaluate manic symptoms at baseline and over time. The total scale score ranges from 0 to 60, where higher scores indicate more severe mania.

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Registry information

Official study title

Ketamine Treatment Safety and Tolerability in Psychiatric Inpatient Care Delivered at Depatment of Psychiatry, Medical University of Gdańsk, Poland

Acronym: KetGD

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Oct 4, 2022
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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