← 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.

Must not have

Presence of a contraindication to ketamine or midazolam, 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

Use of prohibited concomitant medications, including other forms of ketamine or esketamine, benzodiazepines, monoamine oxidase inhibitors, stimulants, medical or recreational cannabis of any form.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have allergies or health conditions that make ketamine or midazolam 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.

Select...

I have not had major neurological issues or strokes in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

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

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 Rate

Suicidality

+2 more

Side effects data

From 2020 Phase 4 trial • 75 Patients • NCT03156504

Lightheadedness with low blood pressure

Pump Malfunction

PTSD

100%

80%

60%

40%

20%

Study treatment Arm

Ketamine

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1900

0 / 7Eligibility criteria met