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Ketamine for Bipolar Disorder (KET-BD Trial)
KET-BD Trial 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.
KET-BD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowKET-BD Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 4 trial • 75 Patients • NCT03156504KET-BD Trial Design
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- I do not have allergies or health conditions that make ketamine or midazolam unsafe for me.My bipolar depression hasn't improved after trying two or more recommended treatments.I am not using ketamine, benzodiazepines, MAOIs, stimulants, or any form of cannabis.I have been diagnosed with Bipolar I or II and am currently having a major depressive episode without experiencing psychosis.I am between 21 and 65 years old.I am currently experiencing symptoms of mania or bipolar disorder.I am on a stable mood stabilizer treatment as per guidelines.I have not had major neurological issues or strokes in the last year.
- Group 1: Ketamine
- Group 2: Midazolam
- 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
Are we currently enrolling patients for this research project?
"The clinical trial is currently recruiting patients, with 100 people needed from 1 medical center. The information was first posted on 4/30/2022 and last edited on 9/26/2022 according to clinicaltrials.gov"
Which types of patients would be ideal candidates for this clinical trial?
"This psychiatric clinical trial is only for patients with manic disorder who also fall in the age range of 21 to 65. Out of the 100 total slots, how many will you take?"
Will this experiment include any test subjects who are middle-aged or older?
"Theage range this study is targeting is 21-65 years old."
Why is Ketamine given to patients?
"Ketamine has been shown to be an effective treatment for seizures, epileptic episodes, and amnesia."
How many people are included in the research project?
"Yes, according to the information available on clinicaltrials.gov, this trial is currently recruiting patients. The listing was created on April 30th, 2022 and updated on September 26th, 2022. They are looking for 100 volunteers at a single site."
What are the known risks associated with Ketamine?
"There is some data supporting Ketamine's safety, but none yet for efficacy. Our team at Power rated it a 2."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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