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Ketamine for Treatment-Resistant Bipolar Depression (KET-BD-Sustain Trial)

Phase 2
Recruiting
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
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

KET-BD-Sustain Trial 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.Check my eligibility
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.See study design
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.

KET-BD-Sustain Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.

KET-BD-Sustain Trial 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

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 Rates
Treatment Emergent Adverse Events

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-Sustain 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?

University Health Network, TorontoLead Sponsor
1,463 Previous Clinical Trials
483,474 Total Patients Enrolled
14 Trials studying Bipolar Disorder
1,182 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

Frequently Asked Questions

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

Am I eligible to participate in this trial?

"This clinical research study is accepting applications from people between the ages of 21 to 65 suffering from bipolar disorder. Essential criteria for admission include: providing voluntary informed consent, meeting DSM-5 criteria and having an inadequate response to two or more first line treatment trials as per CANMAT guidelines, being in a current depressive episode with no psychotic features verified by a psychiatrist at the start of parent trial, receiving guideline concordant pharmacotherapy without recent changes and undergoing either antidepressant response (change in MADRS score ≥ 50% at day 14) or experiencing symptom remission (MADRS score < 12 on day 14)."

Answered by AI

What potential hazards might accompany the use of Ketamine Hydrochloride?

"Ketamine Hydrochloride scored a 2 on our scale given the limited data concerning its efficacy, but enough evidence of safety to place it in Phase 2."

Answered by AI

Is there a mechanism in place for recruiting participants to this experiment?

"As listed on clinicaltrials.gov, this study is actively recruiting participants and has been since August 10th 2022. The listing was last updated on the preceding day (August 9th)."

Answered by AI

Are participants aged 40 or above eligible for this trial?

"To participate in this research, the required age range is between 21 and 65 years old as set forth by the inclusion criteria."

Answered by AI

How many persons are enrolled in this medical trial?

"Affirmative. Per the information found on clinicaltrials.gov, this medical study has been open for recruitment since 8/10/2022 and was recently updated on 8/9/2022. The trial requires 60 participants to be recruited from 2 different sites."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Toronto Western Hospital
Canadian Rapid Treatment Center of Excellence (CRTCE)
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What state do they live in?
Minnesota
Michigan
Texas
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have been on other medications, many in fact, and I am willing to try anything.
PatientReceived 1 prior treatment
I have bipolar disorder and feel that it is not currently well-controlled by my medications, nor the other medications I have tried in the past. During my depressive episodes I experience suicidal ideation, and during my manic episodes I make poor choices that impact my relationships and career. I need additional treatment options.
PatientReceived 1 prior treatment
~8 spots leftby Jun 2024