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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
Must not have
Unwilling to stop undergoing structured, individualized psychotherapy. (Such therapy, including CBT, will not be permitted during Phases I and II of the study)
Weight > 119 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 1, day 2 day 7
Awards & highlights
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not willing to pause my current psychotherapy sessions.
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I weigh more than 119 kg.
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I have not had seizures, epilepsy, stroke, brain surgery, head injury, or known brain issues.
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I am currently taking fluoxetine or aripiprazole.
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I have used opioid medication in the last 3 months.
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I cannot lie on my back comfortably for 90 minutes.
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I have a condition like high blood pressure or diabetes that could affect my brain.
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I do not have any serious, unstable illnesses affecting my organs or immune system.
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I had a severe reaction to ketamine in a previous phase.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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
2,869 Previous Clinical Trials
2,777,466 Total Patients Enrolled
687 Trials studying Depression
258,215 Patients Enrolled for Depression
Carlos A Zarate, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
15 Previous Clinical Trials
17,315 Total Patients Enrolled
13 Trials studying Depression
16,920 Patients Enrolled for Depression
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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
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