Ketamine + Methohexital for Depression

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of New Mexico

Disqualifiers: Neurological disorders, Schizophrenia, Drug use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 month

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different anesthesia medications, Ketamine and Methohexital, affect brain waves during electroconvulsive therapy (ECT) for depression. Researchers specifically examine slow-wave changes in the brain using a tool called dcEEG. The trial targets individuals diagnosed with major depressive disorder (MDD) or bipolar disorder (BPD) who require ECT due to treatment resistance or a need for quick results. Those with depression characterized by frequent and severe symptoms might be suitable for this study. As an Early Phase 1 trial, this research aims to understand how these anesthesia medications work in people, offering participants a chance to contribute to groundbreaking insights.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ketamine, a drug often used to induce sleep during surgery, can have side effects affecting the brain, spinal cord, heart, and blood vessels. Some individuals might also experience breathing issues, such as throat muscle spasms.

Methohexital, another drug used for the same purpose, is generally safe when administered by a doctor. It has been used for many years and is well-known in hospitals.

Although both drugs can cause side effects, they are usually well-tolerated in controlled settings like hospitals. This trial is in its early stages and aims to assess the safety of these treatments. As a result, the existing safety information might still be limited. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for depression using electroconvulsive therapy (ECT) involve anesthesia like methohexital, which doesn't alter brain wave patterns. However, ketamine is unique because it suppresses slow wave characteristics in the brain. This feature potentially enhances ECT's effects and allows for a quicker response in treating depressive symptoms. Researchers are excited because ketamine could offer a faster and possibly more effective way to enhance ECT outcomes, providing hope for improved treatment experiences.

What evidence suggests that this trial's treatments could be effective for depression?

Research has shown that ketamine, one of the treatments studied in this trial, can reduce symptoms of depression. In some studies, participants experienced a significant drop in depression levels just days after receiving ketamine treatment. Ketamine also helps manage post-surgical pain, potentially reducing the need for other pain medications. In contrast, methohexital, another treatment option in this trial, is a common anesthetic used to induce sleep during procedures but does not specifically target brain activity related to depression. While methohexital is effective for anesthesia, ketamine offers unique benefits for those with depression. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Inclusion Criteria

Structured Clinical Interview for DSM-5 will confirm diagnosis of MDD or BPD-depressed (with or without psychotic features

The clinical indications for ECT including treatment resistance or a need for a rapid and definitive response;

Hamilton Depression Rating Scale 24-item (HDRS-24) > 21;

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive electroconvulsive therapy (ECT) with either ketamine or methohexital as the anesthesia induction agent, and dcEEG data is collected

1 month

First, second, middle, and final ECT treatment sessions

Follow-up

Participants are monitored for cognitive performance and clinical efficacy of ECT

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Ketamine
• Methohexital

How Is the Trial Designed?

Group I: Ketamine Experimental Treatment 1 Intervention

Standard of care anesthesia that suppresses slow wave characteristics

Group II: Methohexital Active Control 1 Intervention

Standard of care anesthesia that does not affect slow wave characteristics

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK470357/

Ketamine - StatPearls - NCBI Bookshelf - NIH Ketamine is highly effective for brief medical procedures that do not necessitate skeletal muscle relaxation and can be utilized as a pre- ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0952818024000424

Efficacy and safety of ketamine as an adjuvant to regional ... Ketamine as an adjuvant to regional anesthesia prolongs the duration of analgesia about 3 h while in peripheral nerve block about 6 h.

3. nature.com nature.com/articles/s41380-023-01945-z

Efficacy and safety of perioperative application of ketamine ... In conclusion, perioperative application of ketamine reduces postoperative depression and pain scores with increased risk of adverse effects.

4. mdpi.com mdpi.com/1420-3049/30/13/2824

Ketamine—From an Anesthetic to a Psychiatric Drug Perioperative subanesthetic doses of ketamine were effective in postoperative pain control, reducing opioid requirements, while displaying minimal adverse ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10187335/

Randomized Trial of Ketamine Masked by Surgical ... The primary outcome was the MADRS score measured 1, 2, and 3 days post-infusion, as previous studies have found the greatest antidepressant ...

6. zoetis.ca zoetis.ca/sds/technical-documents/ketaset-canadian-english-sds.pdf

SAFETY DATA SHEET May be harmful in contact with skin. May be harmful if inhaled. 4 / 8. Material name: Ketamine Hydrochloride Injection. 255 Version #: 01 Issue ...

7. cdn.pfizer.com cdn.pfizer.com/pfizercom/products/material_safety_data/526.pdf

Material Safety Data Sheet May be harmful if absorbed through the skin. Harmful if swallowed (based on animal data) . Known Clinical Effects: Ketamine is an anesthetic agent which is ...

8. northamerica.covetrus.com northamerica.covetrus.com/Content/pdfs/P010177.pdf

SAFETY DATA SHEET Other Hazards. Short Term: Anesthetic drug: may cause central nervous system and cardiovascular system May cause eye irritation. May be harmful if absorbed ...

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/016812s040lbl.pdf

ketamine - accessdata.fda.gov The onset of action of KETALAR is rapid; an intravenous dose of 2 mg/kg of body weight usually produces surgical anesthesia within 30 seconds after injection, ...

10. northamerica.covetrus.com northamerica.covetrus.com/Content/SDS/071071.pdf

SAFETY DATA SHEET VetaKet® (ketamine hydrochloride injection, USP) ... Laryngospasms and other forms of airway obstruction have occurred during ketamine anesthesia.