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IV Ketamine vs. IN Esketamine for MDD TRD

ConditionTreatment Resistant Depression
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorGustavo Vazquez

About this trial

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,

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial 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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Adult outpatients (18-75 years old) with MDD TRD1 intervention

Trial outcomes

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.

Time frame
From enrollment to the end of treatment at 4 weeks

Secondary outcomes

1

Montgomery-Åsberg Depression Rating Scale (MADRS) item 10

The Montgomery-Åsberg Depression Rating Scale (MADRS) item 10 is one of the ten-items of this specific questionnaire that assess suicidal thoughts among individuals with depressive episodes (MDD)

Time frame
From enrollment to the end of treatment at 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gustavo Vazquez

Lead sponsor

Queen's University

Sponsor institution

Centre for Addiction and Mental Health

Collaborator

Envision Mind Care

Collaborator

Sunnybrook Health Sciences Centre

Collaborator

Djavad Mowafaghian Centre for Brain Health

Collaborator

Source ClinicalTrials.gov
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