Trial comparing treatments for Depressive Disorder, Treatment-Resistant
Official title A Study of Esketamine Nasal Spray Versus Placebo Spray in Adult Participants With Treatment-resistant Depression
ClinicalTrials.gov ID: NCT07716098
What this study is testing
What is Esketamine 56 mg?
Esketamine 56 mg is an investigational medicine, being studied as a potential treatment for depressive disorder, treatment-resistant.
Also referred to as JNJ-54135419.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate how well each individual dose of esketamine (56 milligrams [mg] and 84 mg) works when compared with placebo in improving depressive symptoms in participants with treatment resistant depression (individuals with major depressive disorder [MDD] who have not responded to at least 2 different antidepressant treatments given at an adequate dose for an adequate duration in the current episode of depression).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant must meet the diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnostic criteria for single-episode major...
- Participant must have had nonresponse (less than or equal to [\ =2 oral antidepressant treatments in the current episode of depression, assessed...
- The participant's current major depressive episode, depression symptom severity, and antidepressant treatment response in the current depressive...
- Participant must be comfortable with self-administration of nasal spray medication and be able to follow the nasal spray administration instructions...
- A female participant of childbearing potential must have a negative highly sensitive serum (β-human chorionic gonadotropin [β-hCG]) at the start of...
You likely can't join if
- The participant has used ketamine/esketamine (lifetime)
- The participant's depressive symptoms have demonstrated nonresponse in the current major depressive episode to an adequate course of treatment with...
- Participant has received vagal nerve stimulation (VNS) or deep brain stimulation (DBS) in the current episode of depression
- Participant has homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 6 months...
- Participant has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria, except nicotine or caffeine, within 6...
- Participant has a current or history of seizures (uncomplicated childhood febrile seizures with no sequelae are not exclusionary)
The study team makes the final eligibility decision.
Where it's taking place
- Redlands, California, United States
- San Diego, California, United States
- Marietta, Georgia, United States
- Skokie, Illinois, United States
- Cedarhurst, New York, United States
- New York, New York, United States
- Bellevue, Washington, United States
- Kawasaki, Japan
- Kobe, Japan
- Kodaira-shi, Japan
- Maebashi, Japan
- Minatoku, Japan
- Mitaka, Japan
- Nagasaki, Japan
- Sapporo, Japan
- Setagaya Ku, Japan
- Shibuya-ku, Japan
- Tottori, Japan
- Taichung, Taiwan
- Taipei, Taiwan
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Redlands, California, United States; San Diego, California, United States; Marietta, Georgia, United States; Skokie, Illinois, United States; Cedarhurst, New York, United States; New York, New York, United States and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.