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Ketamine Infusions for Bipolar Depression(KET-BD-Sustain Trial)
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.
- Bipolar Disorder
- Depression, Bipolar Disorder
KET-BD-Sustain Trial Eligibility Criteria
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
KET-BD-Sustain Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Side effects dataFrom 2020 Phase 4 trial • 75 Patients • NCT03156504
Awards & Highlights
KET-BD-Sustain Trial Design
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Who is running the clinical trial?
- You have been diagnosed with Bipolar I or II Disorder, currently experiencing a Major Depressive Episode without psychotic featuresYou have had a serious mental illness like schizophrenia or schizoaffective disorder at any point in your life.You have recently had thoughts of hurting yourself or have attempted suicide in the past three months and needed to be in the hospital against your will.You have a history of neurological disorders like seizures, recent stroke, major head injuries, or blood vessel abnormalities in the brain.You are male or female between the age of 21 and 65, inclusive.You have a history of being addicted to ketamine (a type of drug).You currently have severe mental health issues like hallucinations or substance addiction.
- Group 1: Ketamine
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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)."
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."
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)."
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."
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."
Who else is applying?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
What state do they live in?
How many prior treatments have patients received?
Why did patients apply to this trial?
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