IV Ketamine Vs. in Esketamine for MDD TRD

NCT06488586 | Recruiting FDA Drug

• 2 other identifiers: GHVDepartment of Psychiatry.
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

• Montgomery-Åsberg Depression Rating Scale (MADRS)

  The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which mental health professionals use to measure the severity of depressive episodes in patients with mood disorders.

  From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (1)

• Montgomery-Åsberg Depression Rating Scale (MADRS) item 10

  From enrollment to the end of treatment at 4 weeks

Study Arms (1)

Adult outpatients (18-75 years old) with MDD TRD

Participants consisted of adult outpatients (18-75 years old) with unipolar depression experiencing major depressive episodes as determined by the DSM5 and characterized as MDD-TRD, diagnosed with major depressive disorder as outlined by the DSM5 and experienced at least two previous failed antidepressant treatments of adequate dose and duration for the current episode. IV ketamine or IN esketamine are provided as standard-of-care, add-on treatments. Benzodiazepines, naltrexone, lamotrigine, gabapentin and pregabalin, are discontinued prior to the start of the treatment and for the duration of treatment. Patients with psychosis, main diagnosis of personality disorder, uncontrolled hypertension, substance abuse, currently pregnant or breastfeeding, or who had a previous negative reaction to ketamine or esketamine, are ineligible to receive IV ketamine or IN esketamine.

Drug: Low dose IV Ketamine vs. IN Esketamine

Interventions

Low dose IV Ketamine vs. IN Esketamine DRUG

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.

Adult outpatients (18-75 years old) with MDD TRD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult outpatients (18-75 years old) with unipolar depression experiencing major depressive episodes as determined by the DSM5 and characterized as MDD-TRD (diagnosed with major depressive disorder as outlined by the DSM5) and experienced at least two previous failed antidepressant treatments of adequate dose and duration for the current episode

You may qualify if:

• Adult outpatients (18-75 years old) with unipolar depression experiencing major depressive episodes as determined by the DSM5 and characterized as MDD-TRD (diagnosed with major depressive disorder as outlined by the DSM5) and experienced at least two previous failed antidepressant treatments of adequate dose and duration for the current episode

You may not qualify if:

• Individuals with psychosis, main diagnosis of personality disorder, uncontrolled hypertension, substance abuse, currently pregnant or breastfeeding, or who had a previous negative reaction to ketamine or esketamine, were ineligible to receive IV ketamine or IN esketamine.

Sponsors & Collaborators

• Gustavo Vazquez: lead
• Centre for Addiction and Mental Health: collaborator
• Envision Mind Care: collaborator
• Sunnybrook Health Sciences Centre: collaborator
• Djavad Mowafaghian Centre for Brain Health: collaborator

Study Sites (1)

Providence Care Hospital

Kingston, Ontario, K7L4X3, Canada

RECRUITING

Related Publications (1)

• Gutierrez G, Rosenblat J, Hawken E, Swainson J, Vazquez G. Efficacy and Tolerability of Two Novel "Standard of Care" Treatments-Intranasal Esketamine Versus Intravenous Ketamine-for Treatment-Resistant Depression in Naturalistic Clinical Practice: Protocol for a Pilot Observational Study. JMIR Res Protoc. 2022 May 23;11(5):e34711. doi: 10.2196/34711.

  PMID: 35604752 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Esketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Gustavo H Vazquez, MD,PhD,FRCPC

  Queen's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gustavo H Vazquez, MD,PhD,FRCPC

CONTACT

+1 (613)-544-4900; g.vazquez@queensu.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Psychiatry, Queen's University

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 5, 2024
• Study Start: March 20, 2023
• Primary Completion: March 20, 2026
• Study Completion (Estimated): October 20, 2026
• Last Updated: July 10, 2024

Record last verified: 2024-06

Locations

CA (1)