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Ketamine for Treatment-Resistant 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.
KET-BD-Sustain Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowKET-BD-Sustain 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-Sustain Trial Design
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- I have been diagnosed with Bipolar I or II and am currently having a major depressive episode without psychosis.I have been diagnosed with Bipolar I or II and am currently having a major depressive episode without psychosis.I have not had major neurological issues or strokes in the last year.I have been diagnosed with Bipolar I or II and am currently having a major depressive episode without psychosis.I was in the ketamine study for depression and either got much better or my symptoms mostly went away.My current depression hasn't improved after trying two or more recommended treatments.I do not have conditions like uncontrolled high blood pressure, recent heart attack, severe liver or kidney issues, heart failure, or coronary artery disease that would make ketamine unsafe for me.I am between 21 and 65 years old.I was in the ketamine study and couldn't handle 4 doses as decided by my doctor or me.I am not using ketamine, benzodiazepines, MAOIs, stimulants, or any form of cannabis.I am currently experiencing symptoms of mania or bipolar disorder.I have been on a stable dose of medication for my mood disorder for the last month.My current depression hasn't improved after trying two or more recommended treatments.I am on a stable mood stabilizer medication as per guidelines.I am between 21 and 65 years old.
- Group 1: Ketamine
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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."
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