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NMDA Receptor Antagonist
IV Ketamine for Suicidality in Bipolar Disorder (DEEPP Trial)
Toronto, Canada
N/A
Waitlist Available
Led By Yuliya Knyahnytska, MD, PhD
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Individuals currently depressed defined as scoring 14 and above on the Hamilton Rating Scale for Depression-24 Items (HRSD-24)
Be older than 18 years old
Must not have
Stage 2 hypertension defined as a systolic pressure of 140 mm Hg or higher or a diastolic pressure of 90 mm Hg or higher on three consecutive readings taken 5 minutes apart
Any known allergy to the study medication or any component/ingredient of the ketamine preparation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is examining the effect of IV ketamine treatment on acute suicidality in patients with BD, as well as exploring the neurophysiological mechanisms of ketamine's action directly from the cortex in patients with BD.
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Who is the study for?
This trial is for individuals diagnosed with Bipolar Disorder currently in a depressive episode, experiencing suicidal thoughts. Participants must be able to consent and communicate in English, have a depression score of 14+ on HRSD-24, and a suicide ideation score of 9+. Excluded are those with recent substance abuse, heart failure, severe medical illnesses like uncontrolled hypertension or liver issues, psychotic disorders other than bipolar depression, pregnancy/breastfeeding without birth control use.Check my eligibility
What is being tested?
The study tests the effects of Intravenous Ketamine on acute suicidality in patients with Bipolar Depression (BD). It's an open label pilot study that also aims to understand how ketamine affects brain function by studying its neurophysiological mechanisms directly from the cortex.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of IV ketamine can include confusion or disorientation shortly after administration, nausea or vomiting, increased blood pressure and heart rate during infusion. Long-term side effects may vary but could involve memory problems or bladder issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently experiencing depression, as indicated by my HRSD-24 score.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My blood pressure is consistently 140/90 mm Hg or higher.
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I am not allergic to the study medication or its ingredients.
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I have heart failure.
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I do not have any major brain or nerve conditions.
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I am on a high dose of benzodiazepine, anticonvulsant, or opioid medication.
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I have been diagnosed with a specific mental health condition like schizophrenia, bipolar disorder, OCD, or PTSD.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Impact of a series of therapeutic IV Ketamine 40-min infusions on cortical excitation as measured by intracortical facilitation (ICF)
Ketamine
Secondary study objectives
Change in symptom severity of Suicidal Ideation as measured by by the Scale of Suicide Ideation (SSI)
Change in symptom severity of depression as measured by the Hamilton Rating Scale for Depression - 24
Other study objectives
Change in quality of life measures as assessed by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Safety and Tolerability of IV Ketamine as assessed by monitoring of adverse events
Safety and tolerability as assessed by changes in Blood Pressure (BP)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intravenous Ketamine (IV)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intravenous Ketamine (IV)
2022
N/A
~20
Find a Location
Closest Location:Centre for Addiction and Mental Health· Toronto, Canada· 471 miles
Who is running the clinical trial?
Centre for Addiction and Mental HealthLead Sponsor
386 Previous Clinical Trials
84,204 Total Patients Enrolled
Yuliya Knyahnytska, MD, PhDPrincipal InvestigatorCentre for Addiction and Mental Health
1 Previous Clinical Trials
25 Total Patients Enrolled