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Ketamine Infusions for Bipolar Depression(KET-BD-Sustain Trial)

Phase 2
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).
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).
Must not have
Be younger than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up12 weeks
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Bipolar Disorder
  • Depression, Bipolar Disorder

KET-BD-Sustain Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have been diagnosed with Bipolar I or II Disorder, currently experiencing a Major Depressive Episode without psychotic features

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
Lightheadedness with low blood pressure
Pump Malfunction
Study treatment Arm

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine Hydrochloride
Completed Phase 4

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,431 Previous Clinical Trials
482,767 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?
Canadian Rapid Treatment Center of Excellence (CRTCE)
Toronto Western Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What state do they live in?
How many prior treatments have patients received?

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
~16 spots leftby Jun 2024