100 Participants Needed

Ketamine for Depression

Recruiting at 1 trial location
JE
NM
Overseen ByNicholas Murphy
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Baylor College of Medicine
Must be taking: Psychotropic medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The core objective of this study is to enhance the translational potential of this electroencephalogram (EEG) biomarker by using ketamine(KET)-induced gamma potentiation as a prognostic marker of 4-week treatment outcome. Previous research focused exclusively on KET-induced gamma band potentiation (GBP) in the context of a single infusion. Our study design captures the clinical variation associated with real-world treatment resistant depression (TRD) patients and allows us to analyze the relative importance of GBP to antidepressant symptom reduction across the induction phase of treatment. If successful, it provides a compelling rationale for a larger prospective investigation of gamma dynamics as a moderator of outcome to varied TRD therapies which impact the balance of cortical excitation and inhibition.

Will I have to stop taking my current medications?

Participants must be on a stable dose of their current psychotropic medications for at least 4 weeks before the study. However, certain medications, like those affecting specific brain receptors, benzodiazepines over 6mg/day, prescription opioids, and some dietary supplements, must be stopped before the study.

Is ketamine safe for treating depression?

Ketamine has been shown to have rapid antidepressant effects, but common side effects include a sense of detachment from reality and increased blood pressure. These side effects are generally temporary, and the treatment is considered promising with careful monitoring.12345

How is the drug ketamine unique for treating depression?

Ketamine is unique for treating depression because it can produce rapid antidepressant effects, especially when administered subcutaneously (under the skin), which is a convenient and cost-effective method compared to traditional intravenous routes. This makes it particularly beneficial in developing countries, and it has shown promising results with high response rates and manageable side effects.26789

What data supports the effectiveness of the drug ketamine for treating depression?

Research shows that intravenous ketamine can quickly and significantly improve depression symptoms, even in patients who haven't responded to other treatments. Studies have demonstrated its rapid antidepressant effects, providing relief for about 2-3 weeks after treatment.810111213

Are You a Good Fit for This Trial?

This trial is for individuals with treatment-resistant depression, including those diagnosed with Major Depressive Disorder. Healthy subjects are also included to provide a comparison group. Participants must meet specific criteria not detailed here.

Inclusion Criteria

Level of understanding sufficient to agree to all tests and examinations required by the protocol
My mental health medication doses have been stable for at least 4 weeks.
I have been diagnosed with major depression for at least 4 weeks.
See 5 more

Exclusion Criteria

Patients at serious and imminent risk of suicide and not suitable for an outpatient study
Body mass index (BMI) >=40 kg/m2
I recently started cognitive behavioral therapy.
See 19 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive ketamine infusions to assess gamma potentiation as a prognostic marker

4 weeks
8 infusions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
Study exit visit (up to a month after infusion)

What Are the Treatments Tested in This Trial?

Interventions

  • Ketamine
Trial Overview The study tests if brain wave patterns (gamma oscillations) can predict how well patients respond to ketamine therapy over four weeks. It involves comparing the effects of saline (a placebo) and ketamine on these brain waves in people with depression.
How Is the Trial Designed?
3Treatment groups
Active Control
Group I: Healthy ControlsActive Control2 Interventions
Group II: Treatment Resistant DepressionActive Control2 Interventions
Group III: Major Depressive DisorderActive Control2 Interventions

Ketamine is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Ketalar for:
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Approved in European Union as Ketalar for:
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Approved in United States as Spravato for:
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Approved in European Union as Spravato for:
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Approved in Canada as Spravato for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials
1,044
Recruited
6,031,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Published Research Related to This Trial

A 49-year-old woman with severe treatment-resistant major depression experienced significant improvement after receiving 36 sessions of ketamine intravenous therapy over 10 months, resulting in nearly a 50% reduction in her depressive symptoms.
The case suggests that long-term repeated ketamine therapy could be a viable option for patients with treatment-resistant depression, but further research is needed to determine the best treatment protocols.
Intravenous ketamine infusion for a patient with treatment-resistant major depression: a 10-month follow-up.Kwon, JH., Sim, WS., Hong, JP., et al.[2018]
In a European clinical trial, a 55-year-old male with treatment-resistant depression and substance use disorder showed significant improvement in depression symptoms after a single intravenous infusion of ketamine, with reductions in Hamilton Depression Rating Scale (HDRS) scores from 36 to 16 and Beck Depression Inventory (BDI) scores from 26 to 9.
The antidepressant effects of ketamine were rapid, with the patient reporting improvements just 25 minutes into the infusion, and these effects lasted for at least 7 days, demonstrating ketamine's potential as a fast-acting treatment for depression even in patients with co-occurring substance use disorders.
Intravenous ketamine therapy in a patient with a treatment-resistant major depression.Liebrenz, M., Borgeat, A., Leisinger, R., et al.[2022]
Racemic ketamine and its derivative, S-ketamine, have been shown to provide rapid relief from depressive symptoms, with effects lasting approximately 2-3 weeks after treatment, based on multiple clinical trials.
Further research is needed to optimize dosing strategies, especially for specific populations like obese individuals, and to monitor long-term safety regarding cognitive and organ system effects.
Key considerations for the use of ketamine and esketamine for the treatment of depression: focusing on administration, safety, and tolerability.Kritzer, MD., Pae, CU., Masand, PS.[2023]

Citations

Intravenous ketamine infusion for a patient with treatment-resistant major depression: a 10-month follow-up. [2018]
Intravenous ketamine therapy in a patient with a treatment-resistant major depression. [2022]
Key considerations for the use of ketamine and esketamine for the treatment of depression: focusing on administration, safety, and tolerability. [2023]
A retrospective analysis of ketamine intravenous therapy for depression in real-world care settings. [2023]
Ketamine for the treatment of depression. [2022]
Ketamine as a new treatment for depression: a review of its efficacy and adverse effects. [2013]
Subcutaneous Ketamine in Depression: A Systematic Review. [2021]
Use of ketamine and esketamine for depression: an overview of systematic reviews with meta-analyses. [2022]
Influence of formulation and route of administration on ketamine's safety and tolerability: systematic review. [2021]
The Ketamine Side Effect Tool (KSET): A comprehensive measurement-based safety tool for ketamine treatment in psychiatry. [2023]
Ketamine for the acute treatment of severe suicidal ideation: double blind, randomised placebo controlled trial. [2022]
Pharmacokinetics and Safety of Esketamine in Chinese Patients Undergoing Painless Gastroscopy in Comparison with Ketamine: A Randomized, Open-Label Clinical Study. [2022]
Repeated subcutaneous esketamine administration for depressive symptoms and pain relief in a terminally ill cancer patient: A case report. [2021]
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