Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Janssen Research & Development, LLC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participant must meet the Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) diagnostic criteria for single-episode MDD or recurrent MDD, without psychotic features, based upon clinical assessment and confirmed by the MINI. Participants 65 years of age or older must have had the first onset of depression prior to 55 years of age
Participant must have had nonresponse (\<=25% improvement) to \>=2 oral antidepressant treatments in the current episode of depression, assessed using the MGH-ATRQ, and confirmed by documented records (example, medical/pharmacy/prescription records or a letter from a treating physician)
Participant must have an Inventory of Depressive Symptomatology-Clinician rated, 30-item (IDS-C30) total score of \>=34
The participant's current major depressive episode, depression symptom severity, and antidepressant treatment response in the current depressive episode, must be confirmed by the State vs. Trait, Assessibility, Face Validity, Ecological Validity, Rule of Three P's (SAFER) Interview
You may not be if
Participant must be comfortable with self-administration of nasal spray medication and be able to follow the nasal spray administration instructions provided
The participant has used ketamine/esketamine (lifetime)
The participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT) in the current major depressive episode, defined as at least 7 treatments with unilateral/bilateral ECT
Participant has received vagal nerve stimulation (VNS) or has received deep brain stimulation (DBS) in the current episode of depression
Participant has a current or history of seizures (uncomplicated childhood febrile seizures with no sequelae are not exclusionary)
Participant has any anatomical or medical condition that, per the investigator's clinical judgment based on assessment, may impede delivery or absorption of nasal spray study drug
