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Ketamine for Treatment-Resistant Bipolar Depression (KET-BD-Sustain Trial)
Phase 2
Recruiting
Led By Joshua 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
Meets DSM-5 criteria for Bipolar I or II Disorder, currently experiencing a Major Depressive Episode without psychotic features. Diagnosis confirmed by study psychiatrist at the start of the parent KET-BD randomized clinical trial (RCT).
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. Adequate medications confirmed at the start of the parent KET-BD RCT.
Must not have
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)
Presence of a contraindication to ketamine, including a drug allergy, uncontrolled hypertension (baseline systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg), low or labile blood pressure, myocardial infarction within past 12 months, cardiac arrhythmia, moderate to severe hepatic impairment (i.e., Child-Pugh score of B or C), moderate or severe renal impairment (glomerular filtration rate (GFR) < 45 milliliters/min), heart failure, or coronary artery disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
This trial is testing whether repeated doses of ketamine can help maintain antidepressant effects in people with treatment-resistant bipolar disorder depression.
Who is the study for?
Adults aged 21-65 with treatment-resistant bipolar depression, who've had no medication changes in the last month and are on a mood stabilizer. They must have participated in an earlier trial phase, responding well to ketamine or still depressed after midazolam control. No recent manic episodes, uncontrolled blood pressure, heart issues, severe liver/renal impairment, pregnancy/breastfeeding without contraception use, certain drug allergies or substance misuse.
What is being tested?
The study tests maintenance doses of IV Ketamine Hydrochloride over twelve weeks for those with bipolar depression not improved by standard treatments. Participants receive flexible dosing every 2-4 weeks after showing initial improvement from previous infusions. The focus is on sustained antidepressant effects and impact on quality of life and suicidal thoughts.
What are the potential side effects?
Possible side effects include high blood pressure during infusion, feelings of disconnection from reality or hallucinations shortly after administration (dissociation), nausea or vomiting, dizziness, blurred vision and increased heart rate.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Bipolar I or II and am currently having a major depressive episode without psychosis.
Select...
My current depression hasn't improved after trying two or more recommended treatments.
Select...
I am between 21 and 65 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had major neurological issues or strokes in the last year.
Select...
I do not have conditions like uncontrolled high blood pressure, recent heart attack, severe liver or kidney issues, heart failure, or coronary artery disease that would make ketamine unsafe for me.
Select...
I am not using ketamine, benzodiazepines, MAOIs, stimulants, or any form of cannabis.
Select...
I am currently experiencing symptoms of mania or bipolar disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in depression severity using the Montgomery-Asberg Depression Rating Scale (MADRS)
Secondary study objectives
Quality of Life (QOL)
Recruitment and Retention Rates
Suicidality
+2 moreSide effects data
From 2020 Phase 4 trial • 75 Patients • NCT031565041%
Lightheadedness with low blood pressure
1%
Pump Malfunction
1%
PTSD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
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: KetamineExperimental Treatment1 Intervention
Open-label ketamine infusions will be provided on a flexible schedule (every 2-4 weeks) with flexible dosing (0.5-1.0mg/kg over 40 minutes) titrated to optimize benefits, while minimizing the dosage and frequency over a 12-week extension period
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
FDA approved
Find a Location
Who is running the clinical trial?
Joshua RosenblatLead Sponsor
1 Previous Clinical Trials
100 Total Patients Enrolled
University Health Network, TorontoLead Sponsor
1,531 Previous Clinical Trials
504,262 Total Patients Enrolled
Joshua Rosenblat, MD, MScPrincipal InvestigatorToronto Western Hospital, Psychiatry
3 Previous Clinical Trials
222 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major neurological issues or strokes in the last year.I have been diagnosed with Bipolar I or II and am currently having a major depressive episode without psychosis.I was in the ketamine study for depression and either got much better or my symptoms mostly went away.My current depression hasn't improved after trying two or more recommended treatments.I do not have conditions like uncontrolled high blood pressure, recent heart attack, severe liver or kidney issues, heart failure, or coronary artery disease that would make ketamine unsafe for me.I am between 21 and 65 years old.I was in the ketamine study and couldn't handle 4 doses as decided by my doctor or me.I am not using ketamine, benzodiazepines, MAOIs, stimulants, or any form of cannabis.I am currently experiencing symptoms of mania or bipolar disorder.I have been on a stable dose of medication for my mood disorder for the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Ketamine
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Bipolar Depression Patient Testimony for trial: Trial Name: NCT05339074 — Phase 2