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IV Ketamine Vs. in Esketamine for MDD TRD

NCT06488586 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2024-07-10

No results posted yet for this study

Summary

The goal of this observational study is to learn about the comparative acute effects of ketamine vs esketamine in participants over the age of 18 for the treatment of their severe depression and suicidal ideations.

Participants are already taking antidepressants and/or antipsychotics as part of their regular medical care for depression,

Conditions

Interventions

DRUG

Low dose IV Ketamine vs. IN Esketamine

For IV ketamine treatment, ketamine is administered at 0.5mg/kg over 40 minutes. For IN esketamine treatment, esketamine is administered as a nasal spray, two sprays per nostril (56mg total) for the first treatment and three sprays per nostril (84mg) for the rest of the acute series. All treatments are administered at the academic center under the supervision of a mental health care professional. Patients are asked to come fasting at least two hours prior to treatment and to remain resting in the treatment room throughout the dosing session. Throughout each dosing session, blood pressure, oxygen levels, and onset, duration and severity of common side effects are recorded by nursing staff and/or physicians. Patients are discharged after a minimum of 30 minutes post administration, provided that the vital signs return to baseline and that the patient is calm, alert, and oriented.

Sponsors & Collaborators

  • Centre for Addiction and Mental Health

    collaborator OTHER

  • Envision Mind Care

    collaborator UNKNOWN

  • Sunnybrook Health Sciences Centre

    collaborator OTHER

  • Djavad Mowafaghian Centre for Brain Health

    collaborator UNKNOWN

  • Gustavo Vazquez

    lead OTHER

Principal Investigators

  • Gustavo H Vazquez, MD,PhD,FRCPC · Queen's University

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-20
Primary Completion
2026-03-20
Completion
2026-10-20
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06488586 on ClinicalTrials.gov