Intranasal Ketamine for Depression and Suicidal Thoughts
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.12345Why 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.678910
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intranasal dose of ketamine or placebo
Follow-up
Participants are monitored for rapid and sustained antisuicidal and antidepressant effects
What Are the Treatments Tested in This Trial?
Interventions
- Intranasal ketamine
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor