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i-CBT + Ketamine for Depression (Ket-CBT Trial)

Phase 2
Recruiting
Led By Rodrigo Mansur
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meets DSM-5 criteria for Major Depressive Disorder, currently experiencing a Major Depressive Episode (MDE) without psychotic features. Diagnosis will be confirmed using the Mini-International Neuropsychiatric Interview (MINI) conducted by a delegated physician or trained research study staff
Must present with a moderate to severe depressive episode, as determined by the MADRS score greater than 21
Must not have
Currently has symptoms of mania or hypomania or mixed state bipolar, as determined by the Young Mania Rating Scale (YMRS) score greater than 12
History of neurological disorders (including, but not limited to, uncontrolled seizure disorder, history of stroke within past 12 months, major head injuries, aneurysmal vascular disease [including thoracic and abdominal aorta, intracranial, and peripheral arterial vessels], arteriovenous malformation, or intracerebral hemorrhage)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes post infusion, at day 30, weekly after day 30 up to day 91.
Awards & highlights

Summary

This trial aims to see if combining internet-based cognitive behavioural therapy (i-CBT) with IV ketamine treatment can effectively reduce suicidal thoughts and behaviors in individuals with depression. The study will involve 110

Who is the study for?
This trial is for individuals with treatment-resistant depression who have had recent suicidal thoughts or behaviors. Participants must not have responded to previous treatments and are willing to undergo internet-based cognitive therapy and receive IV drug treatments.
What is being tested?
The study tests if combining i-CBT (internet-delivered Cognitive Behavioural Therapy) with IV ketamine reduces suicidality more effectively than i-CBT with a control, Midazolam. Half the participants will get ketamine; the other half will get Midazolam, alongside weekly i-CBT sessions for 13 weeks.
What are the potential side effects?
IV Ketamine may cause disorientation, dizziness, nausea, elevated blood pressure, and mood swings. Midazolam can induce sleepiness, memory issues, reduced alertness and coordination problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Major Depressive Disorder without psychosis.
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I am experiencing a severe depressive episode.
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My depression hasn't improved after two standard treatments.
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I am between 21 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently experiencing symptoms of mania or hypomania.
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I have not had major neurological issues or strokes in the last year.
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I cannot take ketamine or midazolam due to health issues like allergies, heart problems, or severe liver/kidney disease.
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I am currently undergoing cognitive behavioral therapy or similar treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes post infusion, at day 30, weekly after day 30 up to day 91.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes post infusion, at day 30, weekly after day 30 up to day 91. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Suicidality severity using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Secondary study objectives
Addiction Potential Using the Drug Liking and Craving Questionnaire (DLCQ)
Anxiety using the Generalized Anxiety Disorder-7 (GAD-7)
Automatic negative self-schema using the Depression Implicit Association Test (Depression IAT)
+29 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: i-CBT and IV ketamineExperimental Treatment2 Interventions
Participants will receive internet-based cognitive therapy (i-CBT) for 13 weeks. During the first 4 weeks of i-CBT, participants will also be administered 6 infusions of ketamine intravenously. The first two infusions will be dosed at 0.5 mg/kg over a period of 40 mins. For infusions 3 and 4, patients will be flexibly-dosed between 0.5 mg/kg to 0.75 mg/kg, depending on clinical response to first two infusions. For infusions 5 and 6, patients will be flexibly-dosed between 0.5-0.85 mg/kg, depending on the clinical response to the first 4 infusions.
Group II: i-CBT and IV midazolamActive Control2 Interventions
Participants will receive internet-based cognitive therapy (i-CBT) for 13 weeks. During the first 4 weeks of i-CBT, participants will also be administered 6 infusions of midazolam intravenously. The first two infusions will be dosed at 0.02 mg/kg over a period of 40 mins. For infusions 3 and 4, patients will be flexibly-dosed between 0.02 mg/kg to 0.03 mg/kg, depending on clinical response to first two infusions. For infusions 5 and 6, patients will be flexibly-dosed between 0.02 mg/kg to 0.035 mg/kg, depending on the clinical response to the first 4 infusions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine hydrochloride
2022
Completed Phase 4
~40

Find a Location

Who is running the clinical trial?

Ontario Shores Centre for Mental Health SciencesOTHER
13 Previous Clinical Trials
2,108 Total Patients Enrolled
University Health Network, TorontoLead Sponsor
1,514 Previous Clinical Trials
500,095 Total Patients Enrolled
Rodrigo MansurPrincipal InvestigatorUniversity Health Network, Toronto
~47 spots leftby Apr 2025
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