← Back to Search

Ketamine for Bipolar Disorder (KET-BD Trial)

Phase 2
Recruiting
Led By Joshua D Rosenblat, MD,MSc
Research Sponsored by Joshua Rosenblat
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current depressive episode has inadequate response to two or more adequate first-line treatment trials for bipolar depression, as per the 2018 CANMAT Bipolar Disorder Guidelines. First line treatment trials include the use of lithium, valproate, carbamazepine, lamotrigine and/or any antipsychotic medication.
Meets DSM-5 criteria for Bipolar I or II Disorder, currently experiencing a Major Depressive Episode without psychotic features. Diagnosis will be confirmed using the Mini-International Neuropsychiatric Interview (MINI) conducted by a delegated physician or trained research study while assessing eligibility.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

KET-BD Trial Summary

This trial will study the effects of four doses of ketamine on people with treatment-resistant bipolar disorder, to see if it is an effective, safe and tolerable treatment. The primary outcome will be change in Montgomery-Åsberg Depression Rating Scale (MADRS) scores from baseline to day 14.

Who is the study for?
This trial is for adults aged 21-65 with moderate to severe bipolar depression that hasn't improved after trying at least two standard treatments. Participants must be on a stable medication regimen and not currently experiencing mania or psychosis. Pregnant or breastfeeding women, those with certain medical conditions, or recent substance abuse are excluded.Check my eligibility
What is being tested?
The study tests if four doses of IV ketamine can safely reduce depression symptoms in treatment-resistant bipolar disorder (TRBD) patients compared to midazolam, a control drug. It's a phase II trial measuring the change in depression severity over two weeks and monitoring quality of life and suicidal thoughts.See study design
What are the potential side effects?
Ketamine may cause side effects like high blood pressure, disorientation, nausea, potential for abuse, and dissociation (feeling detached from reality). Midazolam can induce sleepiness, memory issues, dizziness and sometimes breathing difficulties.

KET-BD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My bipolar depression hasn't improved after trying two or more recommended treatments.
Select...
I have been diagnosed with Bipolar I or II and am currently having a major depressive episode without experiencing psychosis.
Select...
I am between 21 and 65 years old.

KET-BD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in depression severity using the Montgomery Asberg Depression Rating Scale (MADRS)
Secondary outcome measures
Quality of Life (QOL)
Recruitment and Retention Rate
Suicidality
+2 more

Side effects data

From 2020 Phase 4 trial • 75 Patients • NCT03156504
1%
Lightheadedness with low blood pressure
1%
Pump Malfunction
1%
PTSD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine

KET-BD Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: KetamineExperimental Treatment1 Intervention
Four infusions of ketamine will be administered over two weeks. The first two infusions will be dosed at 0.5mg/kg over a period of 40 minutes. 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.
Group II: MidazolamActive Control1 Intervention
Four infusions of midazolam will be administered over two weeks. The first two infusions will be dosed at 0.02mg/kg over a period of 40 minutes. 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine Hydrochloride
2018
Completed Phase 4
~1000

Find a Location

Who is running the clinical trial?

Joshua RosenblatLead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Bipolar Disorder
60 Patients Enrolled for Bipolar Disorder
University Health Network, TorontoLead Sponsor
1,483 Previous Clinical Trials
486,317 Total Patients Enrolled
15 Trials studying Bipolar Disorder
1,266 Patients Enrolled for Bipolar Disorder
Joshua D Rosenblat, MD,MScPrincipal InvestigatorToronto Western Hospital, Psychiatry

Media Library

Ketamine Clinical Trial Eligibility Overview. Trial Name: NCT05004896 — Phase 2
Bipolar Disorder Research Study Groups: Ketamine, Midazolam
Bipolar Disorder Clinical Trial 2023: Ketamine Highlights & Side Effects. Trial Name: NCT05004896 — Phase 2
Ketamine 2023 Treatment Timeline for Medical Study. Trial Name: NCT05004896 — Phase 2
Bipolar Disorder Patient Testimony for trial: Trial Name: NCT05004896 — Phase 2
~30 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top