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Ketamine for Bipolar Disorder (KET-BD Trial)

Phase 2
Recruiting
Led By Joshua D Rosenblat, MD,MSc
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
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 2 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
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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 ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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)
The recruitment rate
The retention rate
+1 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
~910

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,419 Total Patients Enrolled
14 Trials studying Bipolar Disorder
1,142 Patients Enrolled for Bipolar Disorder
Joshua D Rosenblat, MD,MScPrincipal InvestigatorToronto Western Hospital, Psychiatry
Rodrigo B Mansur, MD,PhDPrincipal 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we currently enrolling patients for this research project?

"The clinical trial is currently recruiting patients, with 100 people needed from 1 medical center. The information was first posted on 4/30/2022 and last edited on 9/26/2022 according to clinicaltrials.gov"

Answered by AI

Which types of patients would be ideal candidates for this clinical trial?

"This psychiatric clinical trial is only for patients with manic disorder who also fall in the age range of 21 to 65. Out of the 100 total slots, how many will you take?"

Answered by AI

Will this experiment include any test subjects who are middle-aged or older?

"Theage range this study is targeting is 21-65 years old."

Answered by AI

Why is Ketamine given to patients?

"Ketamine has been shown to be an effective treatment for seizures, epileptic episodes, and amnesia."

Answered by AI

How many people are included in the research project?

"Yes, according to the information available on clinicaltrials.gov, this trial is currently recruiting patients. The listing was created on April 30th, 2022 and updated on September 26th, 2022. They are looking for 100 volunteers at a single site."

Answered by AI

What are the known risks associated with Ketamine?

"There is some data supporting Ketamine's safety, but none yet for efficacy. Our team at Power rated it a 2."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Toronto Western Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I've tried several medications that haven't improved my ability to enjoy things. I'm always struggling to enjoy activities in manic and depressive phases.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

I'm an American citizen, not currently living in the US. Does that matter?
PatientReceived no prior treatments
~34 spots leftby Apr 2025