Ketamine for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests how ketamine, administered in varying dosages, affects depression symptoms and brain activity, measured using EEG (a test that records brain waves). Researchers aim to determine if ketamine can improve depression symptoms and identify patterns in brain waves. Individuals diagnosed with major depression and on stable antidepressant medication for at least six weeks might be suitable candidates. As a Phase 1 trial, this research seeks to understand how ketamine works in people, offering participants the opportunity to be among the first to receive this treatment.
Will I have to stop taking my current medications?
If you're taking antidepressants, you can continue as long as your dose has been stable for at least 6 weeks. However, you cannot take antipsychotics or medications that interact with GABA or glutamate, like benzodiazepines or anti-epileptics.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that ketamine infusions can be relatively safe for treating depression. In one study, patients did not exhibit suicidal or addictive behaviors during treatment. Some participants experienced mild side effects, but these were not serious. Another study found that repeated ketamine treatments significantly reduced depression symptoms over two years. Researchers monitored safety by checking reported side effects, which were generally manageable. These findings suggest that ketamine is well-tolerated for treating depression. However, it is important to note that this trial is in the early stages and primarily aims to understand ketamine's effects.12345
Why are researchers excited about this trial's treatments?
Unlike the standard antidepressants that often take weeks to show effectiveness, ketamine has the potential to deliver rapid relief from depression symptoms, sometimes within hours. This makes it unique compared to typical options like SSRIs or SNRIs, which don’t work as quickly. Ketamine works by targeting the brain's glutamate system, offering a new mechanism of action different from traditional treatments that focus on serotonin. Researchers are excited about its potential to quickly alleviate severe depression symptoms, especially for those who haven’t responded to other treatments.
What evidence suggests that this trial's treatments could be effective for Depression?
Research has shown that ketamine can effectively treat depression. In one study, after just three ketamine treatments, 52% of participants experienced enough improvement in severe depression symptoms to be considered in remission. Another study found that 55% of patients who received ketamine had a significant reduction in depression symptoms, comparable to those who received electroconvulsive therapy (ECT), a well-known treatment. Additionally, about 55% of patients with treatment-resistant depression had positive results with low-dose ketamine infusions. This trial will explore different dosages of ketamine, including low, medium, and high levels, to assess their effectiveness. These studies provide strong evidence that ketamine can effectively reduce depressive symptoms for many people.35678
Are You a Good Fit for This Trial?
This trial is for individuals with depression, including Major Depressive Disorder, who are interested in participating in a study to develop an EEG-based biomarker related to ketamine treatment effects.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive various doses of ketamine infusion to assess effects on depressive symptoms and EEG signals
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ketamine
Trial Overview
The trial is testing three different doses of ketamine (0.25 mg/kg, 0.5 mg/kg, and 0.75 mg/kg) to see how they affect symptoms of depression and brain activity as measured by EEG.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
0.5 mg/kg ketamine infusion
0.25 mg/kg ketamine infusion
0.75 mg/kg ketamine infusion
Find a Clinic Near You
Who Is Running the Clinical Trial?
Soterix Medical
Lead Sponsor
Columbia University Irving Medical Center, New York, NY
Collaborator
Citations
Clinical Outcomes of Intravenous Ketamine Treatment for ...
After 6 weeks of treatment, 26% had a 50% improvement in PHQ-9 score (response) and 15% had PHQ-9 score ≤ 5 (remission). These improvements were ...
2.
michiganmedicine.org
michiganmedicine.org/health-lab/ketamines-promise-severe-depression-grows-major-questions-remainKetamine's promise for severe depression grows, but major ...
After just three infusions of ketamine over 11 days, 52% of participants saw their severe depression ease so much they achieved remission.
3.
massgeneralbrigham.org
massgeneralbrigham.org/en/about/newsroom/press-releases/study-finds-ketamine-effective-as-ect-for-major-depressionStudy Finds Ketamine is at Least as Effective as ECT for ...
The researchers found that 55 percent of those receiving ketamine and 41 percent of those receiving ECT reported at least a 50 percent ...
IV low dose ketamine infusions for treatment resistant ...
The results showed a significant reduction in depressive symptoms and suicide ideation (SI) by treatment endpoint. 54.93% of patients responded to the treatment ...
Serial Ketamine Infusions as Adjunctive Therapy to ...
In this randomized clinical trial, serial intravenous ketamine was not significantly more effective than serial midazolam in reducing depressive ...
Therapeutic and Safety Outcomes of Intravenous Ketamine ...
Conclusions: In this study, repeated-dose IV ketamine infusions over a 24-month study period resulted in a significant reduction in depression ...
Real World Effectiveness of Maintenance Ketamine ...
Ketamine was determined to be relatively safe, with zero cases of suicidal behaviour and addiction behaviour throughout treatment. One patient ( ...
Intravenous Ketamine for Treatment Resistant Depression
The efficacy outcomes were measured by changes in depression outcomes for IV ketamine. Safety was assessed by reported adverse effects. Results ...
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