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New treatment option for Depressive Disorder, Major
Official title Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response
ClinicalTrials.gov ID: NCT05915013
What this study is testing
What is Ketamine?
Ketamine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for depressive disorder, major.
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 proposed study will assess the combined effect of perampanel and ketamine on the anti-depressant response in individuals with treatment resistant depression. The purpose of this study is to test the hypothesis that stimulation of Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid receptors (AMPAR) is critical to the anti-depressant response of ketamine.
- Phase 1: an early, usually small safety study
- 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 18 to 60
You may be able to join if
- Substudy #2:
- Right-handed as determined by the Edinburgh Handedness Inventory
- Current depression as indicated by a score greater than 17 on the full Hamilton Depression Rating Scale
- Anti-depressant resistant depressive symptoms, defined by a history of failure of one or more adequate anti-depressant trials
- Individuals who have previously received ketamine must have had a positive response. Individuals who report reduced depressive symptoms will be...
You likely can't join if
- Substudy #2:
- A score on the Columbia Suicide Severity Rating Scale in the "intent" or "intent with plan" categories or judged by Dr. Krystal or Dr. Driesen to be...
- Neurological disorder excluding migraine headaches or more than mild head injury. Individuals with migraines will not complete any ketamine infusion...
- 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...
See the full eligibility criteria
Who can join
- Substudy #2:
- Right-handed as determined by the Edinburgh Handedness Inventory
- Current depression as indicated by a score greater than 17 on the full Hamilton Depression Rating Scale
- Anti-depressant resistant depressive symptoms, defined by a history of failure of one or more adequate anti-depressant trials
- Individuals who have previously received ketamine must have had a positive response. Individuals who report reduced depressive symptoms will be treated as ketamine responders and entered directly into the closed label...
- Participants will meet DSM-5 Criteria for MDD as determined by the SCID-5
- All participants given ketamine must be engaged in treatment outside of the research protocol. Those who are not currently in treatment may be referred for treatment.
- Individuals who are receiving pharmacotherapy for depression must have been receiving the current medication and dose for 4 weeks before randomization. In addition, they should have a plan to continue the current regime...
- 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.
- Willing to refrain from caffeine, drug and alcohol use for one week prior to each MRI session
- 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
- Substudy #2:
- A score on the Columbia Suicide Severity Rating Scale in the "intent" or "intent with plan" categories or judged by Dr. Krystal or Dr. Driesen to be at serious risk for suicide.
- Neurological disorder excluding migraine headaches or more than mild head injury. Individuals with migraines will not complete any ketamine infusion visits within 24 hours of a migraine. More than mild head injury is...
- 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
- 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
- Insulin-dependent diabetes or non-insulin dependent diabetes that is poorly controlled
- 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 scans.
- A positive screening breathalyzer test or, at the study physicians' discretion, on any breathalyzer test given before the scans. This applies to all people, including those who make criteria for current mild alcohol use...
- 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 MRI scan. people who have taken OTC medication or herbal supplements may still be...
- 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
- History of claustrophobia
- Any clinically significant impairment of color vision or visual acuity after correction available in the scanner
- Presence of cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a Yale Magnetic Resonance Research Center standard pre-MRI screening questionnaire
- people will be advised not to drive or operate heavy machinery for at least 24 hours after completing the infusion.
- 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
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New 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.