Low-Dose Ketamine Effects in Healthy Volunteers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how low doses of ketamine (Ketamine Hydrochloride) affect brain activity in healthy individuals. Researchers aim to identify the smallest dose that produces noticeable changes in brain signals. Participants will attend two sessions to receive ketamine and undergo brain scans to monitor these effects. Healthy individuals who have never used recreational ketamine and have no major medical or psychiatric history may be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that ketamine is generally safe, even at higher doses. In one study, about 12% of participants experienced confusion or hallucinations upon waking after receiving ketamine. Common side effects include nausea, dizziness, and drowsiness, which are typical and usually not serious.
Other studies have also shown that ketamine is well-tolerated in many situations. For example, it does not appear to cause more serious problems than other medications used in emergencies. However, it might increase pressure in the fluid around the brain and spine, so doctors must exercise caution in these cases.
Overall, while some side effects can occur, ketamine is generally safe and well-tolerated for most people.12345Why do researchers think this study treatment might be promising?
While most treatments for conditions like depression require weeks to show effectiveness, ketamine has the potential to show results in just hours or days. Unlike traditional antidepressants that target serotonin or norepinephrine pathways, ketamine works on the brain's glutamate system, which might help reset brain connections more rapidly. This unique mechanism of action has researchers excited, as it offers a faster-acting option for those who need rapid relief.
What evidence suggests that this treatment might be an effective treatment for phBOLD response?
Research has shown that ketamine can effectively treat depression. Specifically, 55% of individuals with treatment-resistant depression experienced improvement after using ketamine without major side effects. It also quickly reduces suicidal thoughts and helps with PTSD and anxiety. Ketamine alters the brain's chemical activity, offering relief when other treatments fail. This trial will examine the effects of low-dose ketamine on the brain in healthy volunteers, aiming to enhance its use for mental health treatments.26789
Are You a Good Fit for This Trial?
This trial is for healthy individuals aged 18-55 who can consent to the study and agree to use reliable birth control. Excluded are those with metal implants, a family history of schizophrenia, positive drug tests, suicidal ideation, psychotropic medication use, past psychiatric disorders (except nicotine), recreational ketamine/PCP use or adverse reaction to ketamine, pregnancy/breastfeeding women, history of violence or significant medical/neurological illnesses.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo two identical ketamine-induced pharmacoBOLD (phBOLD) sessions at least 7 days apart to evaluate ketamine dosing and phBOLD response.
Follow-up
Participants are monitored for safety and effectiveness after ketamine sessions, with potential inpatient monitoring if necessary.
What Are the Treatments Tested in This Trial?
Interventions
- Ketamine Hydrochloride
Trial Overview
The trial is testing how different doses of Ketamine Hydrochloride affect brain activity in healthy volunteers using pharmacoBOLD imaging. Each participant will undergo two sessions with the same dose based on their weight but not exceeding 0.08 mg/kg. The exact dose won't be disclosed to participants; however, it will be known by the physician overseeing the study.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
ketamine
Ketamine Hydrochloride is already approved in United States, European Union, Canada for the following indications:
- Anesthesia
- Pain management
- Depression
- Suicidal ideation
- Anesthesia
- Pain management
- Treatment-resistant depression
- Anesthesia
- Pain management
- Depression
Find a Clinic Near You
Who Is Running the Clinical Trial?
New York State Psychiatric Institute
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator
Citations
Efficacy of ketamine therapy in the treatment of depression
Results: There was a significant improvement in depression, anxiety, and the severity of illness after 2 weeks and 1 month of the last dose of ketamine.
Oral ketamine for the treatment of major depressive and ...
Our results strongly support antidepressant efficacy of oral ketamine treatment in terms of symptom reduction as well as differences in response ...
ketamine - accessdata.fda.gov
REACTIONS HAVE OCCURRED IN APPROXIMATELY 12 PERCENT OF PATIENTS. RECURRENCES HAVE TAKEN PLACE UP TO 24 HOURS POSTOPERATIVELY. NO RESIDUAL PSYCHOLOGICAL EFFECTS ...
Ketamine HCl Prolonged Release Oral Tablets for CRPS
The purpose of this study is to evaluate the efficacy of Ketamine HCl Prolonged Release (PR) tablets in participants with pain due to complex regional pain ...
Ketamine Therapy: What It Is, How It Works & Side Effects
It improves certain mental health symptoms. It may manage conditions like PTSD, social anxiety and more. It reduces suicidal thoughts quickly. ...
Pharmacokinetics, Safety, and Tolerability of (R)-Ketamine ...
The trial results showed that (R)-ketamine hydrochloride injection was safe and well tolerated throughout the study. Overall, the TEAEs and ADRs ...
highlights of prescribing information
Animal data show that Ketamine Hydrochloride Injection may cause harm to the fetus; avoid use during pregnancy, labor, and delivery.
Ketamine Hydrochloride – Application in Therapy and ...
Ongoing Clinical Trials on Ketamine Hydrochloride. Study on the Effects of Ketamine and Esketamine on Brain Activity in Healthy Volunteers. Recruiting.
Ketamine - StatPearls - NCBI Bookshelf
The most common adverse drug reactions associated with ketamine are nausea, vomiting, dizziness, diplopia, drowsiness, dysphoria, and confusion.
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