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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

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 below
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I have been diagnosed with Bipolar I or II and am currently having a major depressive episode without psychosis.
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My current depression hasn't improved after trying two or more recommended 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 have not had major neurological issues or strokes in the last year.
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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.
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I am not using ketamine, benzodiazepines, MAOIs, stimulants, or any form of cannabis.
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I am currently experiencing symptoms of mania or bipolar disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

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 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

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
1 Trials studying Bipolar Disorder
100 Patients Enrolled for Bipolar Disorder
University Health Network, TorontoLead Sponsor
1,514 Previous Clinical Trials
500,145 Total Patients Enrolled
16 Trials studying Bipolar Disorder
1,336 Patients Enrolled for Bipolar Disorder
Joshua Rosenblat, MD, MScPrincipal InvestigatorToronto Western Hospital, Psychiatry
3 Previous Clinical Trials
222 Total Patients Enrolled
2 Trials studying Bipolar Disorder
130 Patients Enrolled for Bipolar Disorder

Media Library

Ketamine Hydrochloride Clinical Trial Eligibility Overview. Trial Name: NCT05339074 — Phase 2
Bipolar Disorder Research Study Groups: Ketamine
Bipolar Disorder Clinical Trial 2023: Ketamine Hydrochloride Highlights & Side Effects. Trial Name: NCT05339074 — Phase 2
Ketamine Hydrochloride 2023 Treatment Timeline for Medical Study. Trial Name: NCT05339074 — Phase 2
Bipolar Disorder Patient Testimony for trial: Trial Name: NCT05339074 — Phase 2
~18 spots leftby Aug 2025
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