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NMDA Receptor Antagonist
Perampanel + Ketamine for Suicidal Thoughts
Phase 2
Recruiting
Led By Naomi Driesen, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 24 hours post infusion
Awards & highlights
Summary
This trial looks at whether a drug called Ketamine can help treat depression and suicidal thoughts by affecting two types of receptors in the brain.
Who is the study for?
This trial is for adults with treatment-resistant depression, PTSD, or bipolar disorder who have suicidal thoughts. They must be educated to at least a 12th-grade level, not pregnant or breastfeeding, and agree to birth control if applicable. Participants should be stable on current psychotherapy or medication regimens for four weeks prior to the study and willing to avoid caffeine, drugs, and alcohol before treatments.
What is being tested?
The study tests whether Ketamine's effects on reducing depression and suicidal thoughts depend on AMPA receptors. It involves comparing Perampanel (an AMPA receptor blocker), Ketamine (a known NMDAR antagonist), and a placebo in participants with certain mood disorders.
What are the potential side effects?
Ketamine may cause disorientation, dizziness, nausea, increased blood pressure or heart rate changes shortly after infusion. Long-term side effects are less clear but could include cognitive changes or bladder issues with repeated use.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 24 hours post infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 24 hours post infusion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in antidepressant response to Ketamine
Change in suicidal ideations in response to Ketamine
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Perampanel + KetamineExperimental Treatment2 Interventions
Participants will receive oral perampanel or placebo, in counterbalanced order, 2.5 hours before a standard, subanesthetic Ketamine infusion (0.5 mg/kg over 40 minutes). Ketamine infusions will be at least three weeks apart. Participants will refrain from caffeine and over-the-counter medication seven days before the infusion day.
Group II: Placebo + KetaminePlacebo Group2 Interventions
Participants will receive oral perampanel or placebo, in counterbalanced order, 2.5 hours before a standard, subanesthetic Ketamine infusion (0.5 mg/kg over 40 minutes). Ketamine infusions will be at least three weeks apart. Participants will refrain from caffeine and over-the-counter medication seven days before the infusion day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Perampanel 6 MG
2018
Completed Phase 4
~20
Ketamine
2011
Completed Phase 4
~1120
Find a Location
Who is running the clinical trial?
National Center for PTSDFED
12 Previous Clinical Trials
1,140 Total Patients Enrolled
1 Trials studying Bipolar Disorder
216 Patients Enrolled for Bipolar Disorder
American Foundation for Suicide PreventionOTHER
34 Previous Clinical Trials
9,810 Total Patients Enrolled
4 Trials studying Bipolar Disorder
226 Patients Enrolled for Bipolar Disorder
VA Connecticut Healthcare SystemFED
84 Previous Clinical Trials
8,500 Total Patients Enrolled
2 Trials studying Bipolar Disorder
176 Patients Enrolled for Bipolar Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a neurological condition, but not migraines or mild head injury.I am currently being treated with Ketamine.I haven't donated more than 500 mL of blood or lost a similar amount in the last 56 days.I have used certain medical devices recently.I have been in psychotherapy for at least 4 weeks and plan to continue during the trial.I am currently seeing a mental health provider while considering Ketamine treatment.I can avoid caffeine, drugs, and alcohol for a week before each Ketamine treatment.I am not pregnant or breastfeeding and will use birth control, or I am unable to become pregnant.I have not taken monoamine oxidase inhibitors in the last 4 weeks.I have tried Ketamine before without feeling better.I have taken prescription or over-the-counter brain-affecting meds or supplements within the last week.I will receive Ketamine in the first week after my period starts, unless I have severe cramps.I have a history of HIV or Hepatitis B.My depression hasn't improved after trying at least one anti-depressant.I have been on the same depression medication and dose for at least 4 weeks.I am currently taking certain medications.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo + Ketamine
- Group 2: Perampanel + Ketamine
Awards:
This trial has 0 awards, including: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.
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