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NMDA Receptor Antagonist
Ketamine for Depression
Phase 1
Recruiting
Led By Carlos A Zarate, M.D.
Research Sponsored by National Institute of Mental Health (NIMH)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Phases I-II
Subjects must have an initial score on the MADRS greater than or equal to 22 and a YMRS score of <12 within one week of study entry and upon entry into Phase II
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 1, day 2 day 7
Awards & highlights
Study Summary
This trial is testing if the antidepressant response of ketamine is linked to AMPA receptors.
Who is the study for?
Adults aged 18-70 with major depressive disorder without psychotic features, who haven't responded to two antidepressant trials. They must be willing to stay at the NIH Clinical Center for 5 weeks and agree to tests like blood draws, MRI, MEG, and possibly sleep tests or TMS. Women able to get pregnant should use birth control or abstain from sex.Check my eligibility
What is being tested?
The trial is testing if ketamine's rapid antidepressant effects are related to AMPA receptors in the brain. Participants will stop taking current psychiatric meds, undergo various tests including brain imaging, then receive either a study drug or placebo orally before getting an intravenous ketamine infusion while their brain activity is monitored.See study design
What are the potential side effects?
Ketamine may cause side effects such as dissociation (feeling detached), dizziness, nausea, increased blood pressure and heart rate shortly after infusion. Long-term side effects are not well known but could include cognitive changes or bladder problems with repeated use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My trial is in an early phase (I or II).
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My depression is moderate to severe, and I have low to no mania symptoms.
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My depression is moderate to severe, and I have low or no mania symptoms.
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I have been experiencing a major depressive episode for at least four weeks.
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I am between 18 and 70 years old.
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I have been diagnosed with Major Depression without psychosis.
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I am between 18 and 70 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, day 1, day 2 day 7
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 1, day 2 day 7
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acute Antidepressant Efficacy: Change from baseline Montgomery Asberg Depression Rating Scale (MADRS) score post ketamine infusion
Continued Antidepressant Efficacy: Change from baseline MADRS score post treatment with ketamine with perampanel versus placebo.
Secondary outcome measures
Acute Antidepressant Efficacy: Change in peripheral measures associated with the administration of ketamine
Acute Antidepressant Efficacy: Change in slow wave activity/slope post ketamine infusion
Acute Antidepressant Efficacy: Change in synaptic plasticity post ketamine infusion
+4 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: 3Experimental Treatment2 Interventions
Individuals in Arm 3 will receive double-blinded placebo and open-label ketamine on the first day, then double-blinded placebo on the second day.
Group II: 2Experimental Treatment4 Interventions
Individuals in Arm 2 will receive double-blinded placebo and open-label ketamine on the first day, then double-blinded perampanel on the second day.
Group III: 1Experimental Treatment3 Interventions
Individuals in Arm 1 will receive double-blinded perampanel and open-label ketamine on the first day, then double-blinded perampanel on the second day.
Find a Location
Who is running the clinical trial?
National Institute of Mental Health (NIMH)Lead Sponsor
2,786 Previous Clinical Trials
2,689,697 Total Patients Enrolled
666 Trials studying Depression
251,514 Patients Enrolled for Depression
Carlos A Zarate, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
14 Previous Clinical Trials
17,279 Total Patients Enrolled
12 Trials studying Depression
16,884 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking medication that is not for mental health issues.My trial is in an early phase (I or II).I am not willing to pause my current psychotherapy sessions.I have been treated with a reversible MAOI before starting Phase II.You are currently at high risk of wanting to harm yourself or others, according to the doctor's assessment.I weigh more than 119 kg.I have not had seizures, epilepsy, stroke, brain surgery, head injury, or known brain issues.You currently have symptoms of psychosis or have been diagnosed with schizophrenia or another mental disorder involving psychosis according to the DSM-IV or DSM-5.I am currently taking fluoxetine or aripiprazole.You have a history of behaving aggressively towards other people.I have tried at least two antidepressants without success, one during my current depressive episode.My depression is moderate to severe, and I have low to no mania symptoms.I am taking psychiatric medication that can be tapered.I haven't used illegal drugs or abused substances, except caffeine or nicotine, in the last 3 months.My depression is moderate to severe, and I have low or no mania symptoms.I have tried at least two antidepressants without success, including one for my current depressive episode.I am receiving or will receive ketamine treatment that is not blinded.I have been experiencing a major depressive episode for at least four weeks.I have used opioid medication in the last 3 months.You have been diagnosed with hearing loss, and participating in imaging procedures might make your hearing worse.I cannot lie on my back comfortably for 90 minutes.I am between 18 and 70 years old.I have a condition like high blood pressure or diabetes that could affect my brain.I have been diagnosed with Major Depression without psychosis.I am between 18 and 70 years old.You feel scared or uncomfortable in small, enclosed spaces.I do not have any serious, unstable illnesses affecting my organs or immune system.I had a severe reaction to ketamine in a previous phase.
Research Study Groups:
This trial has the following groups:- Group 1: 1
- Group 2: 2
- Group 3: 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
Depression Patient Testimony for trial: Trial Name: NCT03973268 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential hazards can arise from Ketamine usage?
"The preliminary evidence for ketamine's efficacy and safety led to it receiving a score of 1 on the Power team assessment scale."
Answered by AI
How many participants are currently receiving treatments as part of this research?
"Affirmative. According to records hosted on clinicaltrials.gov, this scientific investigation is currently in need of volunteers, with the initial post dating back to January 21st 2020 and most recent update occurring on July 6th 2022. The trial seeks 70 participants across 1 centre."
Answered by AI
Are there any vacancies open for participants in this investigation?
"According to the clinicaltrials.gov website, an enrollment push is underway for this research project which was first introduced on January 21st 2020 and updated lastly on July 6th 2022."
Answered by AI
What purpose is this research endeavor attempting to accomplish?
"Primarily, this study aims to measure the sustained antidepressant efficacy of ketamine in combination with perampanel compared to placebo. Secondary objectives include an assessment of slow wave activity and slope following treatment, plasma/serum biomarkers associated with acute antidepressant effects, and gamma power change as indicated by Magnetoencephalography (MEG) data over a baseline period of approximately one day."
Answered by AI
What qualifications are necessary for participation in this trial?
"To take part in the trial, participants must suffer from depression and be within 18-70 years of age. 70 individuals are needed for enrolment."
Answered by AI
How is Ketamine typically applied to treat patients?
"Ketamine is a medication used to manage tonic-clonic seizures, general anesthesia, and induction/maintenance of general anesthesia."
Answered by AI
Is this research open to participants aged 18 and above?
"This trial requires participants to be between 18 and 70 years old. There are 206 medical studies catering to individuals under the legal age of consent, and 1054 for those above 65."
Answered by AI
Who else is applying?
What state do they live in?
California
Other
Maryland
Virginia
How old are they?
18 - 65
What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
3+
Why did patients apply to this trial?
I want to get better. 3 previous drugs and 2 current drugs have not adequately treated my depression.
PatientReceived no prior treatments
I’ve tried countless drugs for depression, major depression, c-ptsd w/anxiety & major depression as well as TMS .
PatientReceived no prior treatments
I've tried many drugs for depression with PTSD. My condition is getting worse and I really need help. I also have ADHD and ASD.
PatientReceived 2+ prior treatments
I’ve tried countless drugs for depression, major depression, c-ptsd w/anxiety & major depression as well as TMS and have not been helped. I’m a single mom, 54 yrs old and my youngest of 3 children is in 10th grade so I only have 2 more years with her before she is off to school. I have lost pretty much everything over the last 8-10 years. I’m basically non-functional 90% of the time. I just want to experience life , longing to be free from the darkness that keeps me from everything I once loved. I don’t even need happiness, just joy and the ability to function and care for my daughter well.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Email
Most responsive sites:
- National Institutes of Health Clinical Center: < 24 hours
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