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New treatment option for Depressive Disorder
Official title The Impact of AMPA Receptor Blockade on Ketamine's Anti-Suicidal Effects
ClinicalTrials.gov ID: NCT05786066
What this study is testing
What is Perampanel 6 MG?
Perampanel 6 MG is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for depressive disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to test the hypothesis that the anti-depressant and anti-suicidal effects of the N-methyl-D-aspartate receptor (NMDAR) antagonist Ketamine is critically dependent on stimulation of Alpha-Amino-3-Hydroxy-5-Methyl-4-Isoxazole Propionic Acid receptors (AMPAR).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 65
You may be able to join if
- Current depression as indicated by a score greater than 17 on the full Hamilton Depression Rating Scale (HDRS-17) AND current major depressive...
- Current suicidal ideation as indicated by a score ≥ 2 on the HDRS-17 Item #3 ("wishes to be dead (or any thoughts of possible death to self)")
- Anti-depressant resistant depressive symptoms, defined by a history of failure of one or more adequate anti-depressant trials
- Participants will meet DSM-5 Criteria for MDD, PTSD or Bipolar Disorder as determined by the SCID-5
- All participants given Ketamine must be engaged in mental health treatment outside of the research protocol. Those who are not receiving treatment...
You likely can't join if
- A score on the Columbia-Suicide Severity Rating Scale [43] in the "intent" or "intent with plan" categories within the last 3 months or judged by Dr...
- Psychiatric hospitalization in the past two months
- Suicide attempt in the past two months
- Neurological disorder excluding migraine headaches or mild head injury. More than mild head injury is indicated by the presence of any of the...
- More than half hour unconsciousness after trauma
- More than one hour post-traumatic amnesia
See the full eligibility criteria
Who can join
- Current depression as indicated by a score greater than 17 on the full Hamilton Depression Rating Scale (HDRS-17) AND current major depressive episode as determined by structured clinical interview (SCID-5)
- Current suicidal ideation as indicated by a score ≥ 2 on the HDRS-17 Item #3 ("wishes to be dead (or any thoughts of possible death to self)")
- Anti-depressant resistant depressive symptoms, defined by a history of failure of one or more adequate anti-depressant trials
- Participants will meet DSM-5 Criteria for MDD, PTSD or Bipolar Disorder as determined by the SCID-5
- All participants given Ketamine must be engaged in mental health treatment outside of the research protocol. Those who are not receiving treatment with a mental health provider at the time of the phone screen may be...
- Individuals who are receiving pharmacotherapy for depression must have been receiving the current medication and dose for 4 weeks before randomization. Those who are not stable on their current medication and dose for 4...
- Individuals who are receiving psychotherapy must have been in treatment for four weeks and should have a plan to continue the current regime of psychotherapy for the duration of the trial. Those who are not stable on...
- Willing to refrain from caffeine, drug, and alcohol use for one week prior to each Ketamine infusion
- Females will be included if they are not pregnant or breastfeeding and agree to utilize a medically accepted birth control method (to include oral, injectable, or implant birth control, condom, diaphragm with...
- Females will receive Ketamine during the follicular phase, i.e., in the first week after the start of the menstrual period, if at all possible. If a prospective participant typically has significant menstrual cramps...
- Able to read and write English
- Have at least a 12th grade education level or equivalent
What rules you out
- A score on the Columbia-Suicide Severity Rating Scale [43] in the "intent" or "intent with plan" categories within the last 3 months or judged by Dr. Krystal or Dr. Driesen to be at serious risk for suicide.
- Psychiatric hospitalization in the past two months
- Suicide attempt in the past two months
- Neurological disorder excluding migraine headaches or mild head injury. More than mild head injury is indicated by the presence of any of the following:
- More than half hour unconsciousness after trauma
- More than one hour post-traumatic amnesia
- Concussive symptoms such as headache, memory problems, nausea/vomiting, irritability, ringing in the ears, dizziness, balance problems, difficulty concentrating or visual disturbances lasting more than one week after...
- Concussive symptoms as defined above in the first week after injury causing more than one day impairment in typical duties.
- Four or more concussive events of less severity than the above will also be grounds for exclusion. These events would include post-trauma symptoms such as the individual being dazed, seeing stars, unconscious for less...
- Current therapeutic treatment with Ketamine
- Previous trial of Ketamine without therapeutic benefit
- Current treatment with topiramate, memantine, or barbiturates within two weeks of randomization
- Daytime use of benzodiazepines
- Current treatment with monoamine oxidase inhibitors within 4 weeks of randomization
- Treatment with a vagal nerve stimulator, ECT or deep brain stimulation within two weeks of randomization
- Psychosis other than psychotic experiences congruent with depressed mood during a period of depression. Individuals experiencing psychosis during the current depressive episode will be excluded.
- Other major medical disorder unless cleared by a study physician
- History of violence unless cleared by Dr. Driesen or Dr. Krystal because of extenuating circumstances. For example, an individual whose violent behavior was always coupled with substance abuse and had obtained stable...
- Individual meets criteria for a diagnosis of substance or alcohol use disorder within the three months prior to screening date. Individuals who meet criteria for mild alcohol use disorder within three months prior to...
- A positive on screening urine drug test or, at the study physicians' discretion, on any drug screens given before the infusion visits.
- A positive screening alcohol breathalyzer or alcohol saliva test or, at the study physicians' discretion, on any alcohol breathalyzer or alcohol saliva test given before the infusion visits.
- A 12-lead ECG at screening has clinically significant abnormalities as determined by the physician reading the ECG.
- Abnormality on clinical chemistry or hematology examination at the pre-study medical screening. people with laboratory parameters outside the reference range for this age group will only be included if the study...
- History of positive HIV or Hepatitis B
- Has received either prescribed or over-the-counter (OTC) centrally active medicine or herbal supplements within the week prior to the Ketamine infusion visit. people who have taken OTC medication or herbal supplements...
- Known sensitivity to Ketamine or heparin
- Resting blood pressure lower than 85/55 or higher than 140/90, or resting heart rate lower than 45/min or higher than 100/min, unless cleared by study physician. If a subject meets these blood pressure entrance...
- History of general intellectual disability
- Donation of blood in excess of 500 mL within 56 days prior to dosing or similar loss of blood due to other causes.
- Potential participants may be eliminated at the discretion of Dr. Krystal, Dr. Driesen, or the study physician.
The study team makes the final eligibility decision.
Where it's taking place
- West Haven, Connecticut, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include West Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.