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Ketamine for Bipolar Disorder
Study Summary
This trial will study the effect of a combination of drugs on people with depression that has not been helped by other treatments. The hypothesis is that one of the drugs (ketamine) works by stimulating a certain receptor in the brain.
- Bipolar Disorder
- Major Depressive Disorder
- Post-Traumatic Stress Disorder
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have been taking topiramate, memantine, or barbiturates in the past two weeks.You are allergic to ketamine or heparin.You are taking benzodiazepines during the day.You have a high risk of wanting to harm yourself or commit suicide, as assessed by the doctors conducting the study.You have a neurological disorder other than migraines or a head injury that caused more than 30 minutes of unconsciousness, more than one hour of memory loss, or persistent symptoms such as headaches, nausea, or difficulty concentrating that lasted for more than a week after the injury. If you have had four or more concussive events with less severe symptoms, you will also be excluded. If you have migraines, you cannot receive ketamine treatment within 24 hours of experiencing a migraine.You primarily use your right hand (as determined by a questionnaire).You have a fear of small or enclosed spaces.You have severe depression based on a test score higher than 17 on the Hamilton Depression Rating Scale.You have a mental condition that causes distorted thinking and perception, except for when you have feelings of extreme sadness along with it.You have a history of intellectual disability.You have received treatment with a vagal nerve stimulator, ECT or deep brain stimulation within two weeks before participating in the study.You are currently receiving ketamine treatment.You have been diagnosed with major depressive disorder, post-traumatic stress disorder, or bipolar disorder by a doctor using a specific set of criteria called the SCID-5.You have been diagnosed with depression and have tried one or more medications for it, but they did not work.You must avoid using caffeine, drugs, and alcohol for one week before each MRI session.You have a significant medical condition that needs to be approved by a study doctor.If you have a history of violence, you need approval from Dr. Driesen or Dr. Krystal to participate in the trial. If you have a history of violence due to substance abuse, but have been sober with no violent incidents, or if you have received successful treatment for impulse control, you may be eligible to participate.
- Group 1: ketamine plus placebo
- Group 2: ketamine plus perampanel
- 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
What is the upper limit of participants in this medical trial?
"Correct. Clinicaltrials.gov verifies that this experiment, which was first uploaded on 11/29/2018 is actively recruiting volunteers. A total of 50 participants are sought from a single medical facility."
Am I eligible to participate in the research protocol?
"This trial is seeking 50 individuals aged 18-65 with manic disorder who meet a variety of additional criteria. These include being right handed, having had positive responses to ketamine treatment in the past, reporting reduced depressive symptoms, and undergoing pharmacotherapy or psychotherapy for mental health issues prior to randomization. Furthermore, participants should abstain from caffeine, drugs and alcohol one week before each MRI scan session; have scores greater than 17 on the Hamilton Depression Rating Scale; exhibit anti-depressant resistant depression symptoms as indicated by failure of one or more prior adequate trials; meet DSM-5 Criteria for Major Depressive Disorder (MDD),"
Is the age criteria for enrollment in this study inclusive of individuals who are above sixty?
"For applicants to become a part of this trial, they must be between the ages 18 and 65. Conversely, there are 384 trials for minors under 18 years old and 1471 for seniors over 65."
Are any opportunities for participation still available in this clinical experiment?
"Affirmative. Clinicaltrials.gov contains information that indicates this medical trial, originally posted on November 29th 2018, is currently enrolling participants. A total of 50 patients are required for the single site taking part in the study."
What precautions should be taken when administering Ketamine to individuals?
"Ketamine's safety rating is low at 1, as its only been through Phase 1 trials and has limited data assessing both efficacy and safety."
To what medical ailments is Ketamine regularly applied?
"Ketamine is a suitable and effective option for treating tonic - clonic seizures, general anesthesia, and induction of general anesthetics."
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?
Why did patients apply to this trial?
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Most responsive sites:
- Yale University: < 48 hours
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