Intranasal Ketamine for Depression and Suicidal Thoughts

Overseen By Courtney Vecera

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Unstable medical condition, Psychotic disorder, Pregnancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a single dose of intranasal ketamine can quickly reduce suicidal thoughts and depression symptoms in individuals with Major Depressive Disorder or Bipolar Disorder. The study focuses on those with recent alcohol abuse issues who are not currently intoxicated or undergoing withdrawal. Participants must have current suicidal thoughts and a history of suicide attempts. They also need to have voluntarily admitted themselves to the Harris County Psychiatry Center. This trial compares the effects of ketamine to a placebo (a non-active substance). As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

Yes, you must not take any medication in the 24 hours before participating in the trial.

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

Research has shown that intranasal ketamine can cause some side effects, but many people find them manageable. Common side effects include nausea, dizziness, and sleepiness. Some individuals might experience temporary confusion or disorientation after use. Reports also mention a tingling sensation or slight numbness.

More serious side effects can occur, though they are less common. These include difficulty breathing or bladder issues. The treatment is generally well-tolerated, but monitoring for these reactions is important, especially for those with anxiety disorders. It is crucial to consult a healthcare provider about any concerns before starting treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for depression?

Unlike standard treatments for depression and alcohol abuse, which often include oral antidepressants and behavioral therapies, intranasal ketamine offers something new and exciting. Researchers are particularly interested in its unique delivery method—administered through the nose—which allows it to act quickly, potentially offering rapid relief from suicidal thoughts. Additionally, ketamine has a novel mechanism of action, targeting the brain's glutamate system, which is different from traditional antidepressants that usually affect serotonin or norepinephrine levels. This could make it a game-changer for people who need fast-acting solutions.

What evidence suggests that intranasal ketamine might be an effective treatment for mood episodes in MDD or BD?

In this trial, participants will receive either intranasal ketamine or a placebo. Research has shown that ketamine as a nasal spray can significantly alleviate depression symptoms. Studies have found it effective and safe for individuals whose depression hasn't improved with other treatments, offering quick relief. In one study, almost half of the participants reported it as 'very effective', and many experienced an improved quality of life. While strong evidence supports its benefits in treating depression, it has not been proven to lower the risk of suicide attempts. Overall, intranasal ketamine appears promising for rapidly improving mood disorders. ^{6 7 8 9 10}

Who Is on the Research Team?

Rodrigo Machado-Vieira, MD, PhD, MSc

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

Inclusion Criteria

The patient is able to provide written informed consent.

DSM-IV-TR criteria for alcohol abuse include continued drinking in spite of problems caused by alcohol, such as drinking in situations where it is inappropriate or having to drink more and more to get the same effects

The person has a high score on the SSI scale (first five items) and a score of 4 or 5 on the Columbia scale.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single intranasal dose of ketamine or placebo

1 day

1 visit (inpatient)

Follow-up

Participants are monitored for rapid and sustained antisuicidal and antidepressant effects

1 week

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Intranasal ketamine
• Placebo

How Is the Trial Designed?

Group I: Intranasal ketamine Experimental Treatment 1 Intervention

Intranasal ketamine

Group II: Placebo Placebo Group 1 Intervention

non-active placebo

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

In a study using rat models of traumatic brain injury caused by maxillofacial impact, ketamine treatment significantly improved recovery time, with treated rats recovering about 2 days faster than the control group.

The results suggest that ketamine may be an effective intervention for enhancing recovery following traumatic brain injuries, indicating its potential therapeutic role in similar human injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Animal experiment of the ketamine effects on traumatic brain injury resulting from impact maxillofacial injury]. Zhang, C., Li, H., Liao, W., et al.[2013]

This study is investigating the safety and feasibility of intranasal ketamine for treating uncontrolled cancer pain, with initial results from 7 subjects indicating potential for effective pain management without the harmful side effects associated with opioids.

If successful, intranasal ketamine could offer a non-opioid alternative for cancer pain relief, improving patients' quality of life while avoiding issues like respiratory depression and constipation that are common with opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Intranasal Ketamine for Reducing Uncontrolled Cancer-Related Pain: Protocol of a Phase I/II Clinical Trial. Shteamer, JW., Harvey, RD., Spektor, B., et al.[2020]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10747365/

The Efficacy and Safety of Intranasal Formulations ...

Thus, intravenously administered ketamine at a subanesthetic dose (0.5 mg/kg) demonstrated a robust and rapid improvement in depressive symptoms ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666915325000848

Intranasal racemic ketamine in treatment-resistant ...

Intranasal racemic ketamine is an effective, well-tolerated treatment for TRD, with favorable safety outcomes and substantial antidepressant effects.

3.

psychiatrist.com

psychiatrist.com/news/study-intravenous-ketamine-vs-intranasal-esketamine/

Study: Intravenous Ketamine Vs. Intranasal Esketamine

For example, a 2022 BMC Psychiatry study reported that intravenous ketamine had a response rate of 70.6 percent compared to 52.9 percent for ...

4.

psychiatryonline.org

psychiatryonline.org/doi/10.1176/appi.ajp.20241177

Six Years After Approval of Esketamine Nasal Spray for ...

Hence, there is still no evidence that esketamine nasal spray (or ketamine) actually reduces the risk of suicide attempts or suicide. What are ...

5.

rapm.bmj.com

rapm.bmj.com/content/48/12/581

Real-world study of intranasal ketamine for use in patients ...

Intranasal ketamine was reported as 'very effective' in 49.1% and the quality of life was considered 'much better' in 35.5%. At the time of the interview, 65.1% ...

6.

fda.gov

fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-professionals-potential-risks-associated-compounded-ketamine-nasal-spray

Potential risks associated with compounded ketamine ...

FDA has become aware of safety reports involving compounded intranasal ketamine to treat psychiatric disorders which may be putting patients at risk.

7.

mayoclinic.org

mayoclinic.org/drugs-supplements/esketamine-nasal-route/description/drg-20458442

Esketamine (nasal route) - Side effects & dosage

This medicine may cause prolonged drowsiness, loss of consciousness, mental changes (eg, confusion about identity, place, and time, feeling of ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8993781/

Adverse Effects of Esketamine for the Treatment of Major ...

The most frequent adverse effects under treatment with esketamine were nausea, dissociation, dizziness, vertigo, hypoesthesia,sedation and paresthesia.

9.

futurepsychsolutions.com

futurepsychsolutions.com/blog/does-nasal-ketamine-treatment-have-side-effects/

Does Nasal Ketamine Treatment Have Side Effects?

Nasal ketamine treatment does not cause fear, but patients with an anxiety disorder may feel fearful if they allow fear ahead of treatment. There is no reason ...

10.

goodrx.com

goodrx.com/conditions/depression/ketamine-side-effects?srsltid=AfmBOopvuHz52R0IFESFiJskOKXpmgnMvYXtLFwX2NZA1gYLO00SWHNS

8 Ketamine Side Effects to Know About When Using It for ...

Ketamine misuse can cause dangerous adverse effects, including trouble breathing and “ketamine bladder” — bladder inflammation that may lead to ...