Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression
The Mechanism of Action Underlying Ketamine's Antidepressant Effects: An Investigation of the AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 70 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 5 weeks, 2 weeks
- Procedures mentioned: Blood draws, Physical exams, MRI scans, Infusions
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "They will have blood tests and a physical exam."
- "Participants will stay at the NIH Clinical Center for 5 weeks."
- "For 2 weeks, participants will taper off their psychiatric medicine."
- "Then they will have the following tests: * Blood draws * Psychological tests * MRI: Participants will lie in a machine that takes pictures of their brain. * MEG: Participants will lie down and do tasks."
- "Notably, both animal and human studies indicate that acute, sub-anesthetic ketamine infusion is associated with robust increases in gamma power."
- "In Phase II, participants will receive an open-label ketamine infusion with a randomized, double-blind, add-on intervention (perampanel vs. placebo)."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether AMPA receptors, parts of brain cells, help ketamine quickly relieve depression. It is for adults ages 18–70 whose major depression has not improved with treatment. Participants stay at the NIH Clinical Center for 5 weeks.
Background: Most drugs that treat mood disorders take a long time to work. Ketamine works within hours. A dose can last for a week or more. Certain receptors in the brain might help ketamine work. A drug that blocks these receptors might affect how it works. Objective: To see if the antidepressant response of ketamine is linked to AMPA receptors. Eligibility: Adults ages 18-70 with major depression disorder without psychotic features Design: Participants will be screened under protocol 01-M-0254. They will have blood tests and a physical exam. Participants will stay at the NIH Clinical Center for 5 weeks. Phase 1 lasts 4 weeks. For 2 weeks, participants will taper off their psychiatric medicine. Then they will have the following tests: * Blood draws * Psychological tests * MRI: Participants will lie in a machine that takes pictures of their brain. * MEG: Participants will lie down and do tasks. A cone lowered on their head will record brain activity. * Optional sleep tests: Electrodes on the scalp and body and belts around the body will monitor participants while they sleep. * Optional TMS: Participants will do tasks while a wire coil is held on their scalp. An electrical current will pass through the coil that affects brain activity. For phase 2, on day 0 participants will take the study drug or a placebo orally. While having a MEG, they will get ketamine infused into a vein in one arm while blood is drawn from a vein in the other arm. On day 1, participants will again take the study drug or a placebo orally. On days 3-7, they will repeat many of the phase 1 tests. Days 8 and 9 are optional and include an open label ketamine treatment and many of the phase 1 tests.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18–70 years old.
- Have major depression without psychosis, such as seeing or hearing things that are not there.
- Have a current period of depression lasting at least 4 weeks.
- Have tried at least 2 antidepressant treatments that did not help enough, including at least 1 during the current period of depression. Certain brain stimulation treatments may count.
- Meet the required scores on depression and mania rating tests. Mania means an unusually high or irritable mood with extra energy.
- Complete the required NIH screening, understand the study, and sign a consent form.
- Agree to stay in the hospital.
- For the optional extra ketamine treatment, finish Phase II and meet its entry rules. If able to become pregnant, agree to use effective birth control or avoid sex during this extra phase.
Who can't join
- Psychosis, schizophrenia, a serious current risk of harming yourself or others, or a history of aggression toward others.
- A substance use disorder in the past 3 months, except caffeine or nicotine; recent illegal drug use; or a disallowed positive alcohol or drug test. Opioid use in the past 3 months also rules you out.
- Serious unstable illness, illness that may affect the brain, unexplained seizures, certain seizure-risk medicines, major abnormal lab results, or a positive HIV test.
- Pregnancy or breastfeeding. The main study rules also list people able to become pregnant as excluded, but give birth control and pregnancy testing rules for them; ask the study team to clarify.
- Psychiatric medicines before Phase II, any non-psychiatric medicines, or fluoxetine or aripiprazole at screening. Psychiatric medicines must be slowly stopped during Phase I. You must also stop structured one-on-one talk therapy during Phases I and II.
- Weight over 119 kg (about 262 pounds), certain metal implants, fear of small spaces, or inability to lie comfortably on your back for up to 90 minutes. Certain hearing problems rule out imaging; certain brain injuries or seizure histories rule out TMS brain stimulation.
- Being a current NIMH employee or staff member, or an immediate family member of one.
- For the optional extra ketamine treatment: a serious or unbearable reaction to ketamine in Phase II, a positive illegal-drug urine test within 24 hours before treatment, pregnancy, breastfeeding, or plans to become pregnant.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
* INCLUSION CRITERIA: Phases I-II 1. 18 to 70 years of age. 2. Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document. 3. All subjects must have undergone a screening assessment under protocol 01-M-0254, "The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers". 4. Subjects must fulfill DSM-IV or -5criteria for Major Depression (Major Depressive Disorder) without psychotic features, based on clinical assessment and informed by a structured diagnostic interview (SCID-P). 5. 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. 6. Lack of response to two adequate antidepressant trials, with \[at least\] one in the current major depressive episode, operationally defined using the Antidepressant Treatment History Form (ATHF); a failed adequate trial of ECT \[or TMS\] would count as an adequate antidepressant trial. 7. Current major depressive episode lasting at least four weeks 8. Agree to be hospitalized Open-Label Ketamine Treatment 1. Participants must have met all inclusion criteria for and completed Study Phase II 2. Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase III. EXCLUSION CRITERIA: Phases I-II 1. Current psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-5. 2. Subjects with a history of substance abuse or dependence diagnosis (DSM-IV) or substance use disorder (DSM-5 equivalent) (except for caffeine or nicotine dependence) within the preceding 3 months. In addition, subjects who currently are using drugs (except for caffeine or nicotine) must not have used illicit substances or known drugs of abuse in the 2 weeks prior to screening and must have a negative alcohol and drug urine test (except for prescribed benzodiazepines or stimulants) at screening. 3. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, coronary artery disease, atherosclerotic ischemic stroke, and atrial fibrillation), endocrinologic, neurologic, immunologic, or hematologic disease. 4. Pregnant or nursing individuals or those who are physically able to become pregnant. Participants who are physically able to become pregnant or cause a pregnancy must use at least one form of effective birth control or remain completely abstinent from sexual intercourse during the entire period of study participation (or until the last clinical labs and ratings). Participants able to become pregnant must have negative urine pregnancy tests no more than 24 hours prior to receiving the study drugs and undergoing imaging procedures. 5. Subjects with one or more seizures without a clear and resolved etiology or current use of medication known to lower seizure threshold. History of seizure (regardless of age or etiology), history of epilepsy in self or first-degree relatives, stroke, brain surgery, head injury, or known structural brain lesion will be excluded from the TMS procedures. 6. Presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications. 7. Clinically significant abnormal laboratory tests. 8. (For imaging procedures) Subjects with hearing loss that has been clinically evaluated and diagnosed and may be worsened through participation in imaging procedures 9. Positive HIV test 10. Weight \> 119 kg 11. Treatment with any concomitant psychiatric medication prior to entering Phase II. \[Medications must be tapered during Phase I.\] 12. Treatment with any non-psychiatric medication/s. 13. Any use of opioid medication in the past 3 months 14. Treatment with a reversible monoamine oxidase inhibitor (MAOI) prior to entering Phase II. \[Medications must be tapered during Phase I.\] 15. Treatment with fluoxetine or aripiprazole at the time of screening. 16. Unwilling to stop undergoing structured, individualized psychotherapy. (Such therapy, including CBT, will not be permitted during Phases I and II of the study.) 17. Presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clip). 18. Participants who are uncomfortable in small closed spaces (have claustrophobia). 19. Are unable to lie comfortably supine for up to 90 minutes and would feel uncomfortable in the MRI and MEG machines. 20. Subjects who, in the investigator s judgment, pose a current serious suicidal or homicidal risk. 21. Subjects who have a history of aggressive behavior towards others 22. A current NIMH employee/staff or their immediate family member Open-Label Ketamine Treatment 1. Intolerable or serious adverse reaction to ketamine during Phase II 2. Participants with a positive urine for an illicit substance no more than 24 hours prior to ketamine treatment. 3. Pregnant or nursing individuals or those who plan to become pregnant.
Study sites (1)
MD
- National Institutes of Health Clinical Center · Bethesda, MD 20892NIH Clinical Center Office of Patient Recruitment (OPR) · Study contact · 800-411-1222 · ccopr@nih.govMore trials in Bethesda