Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-25 @ 4:56 AM
NCT ID:
NCT02918318
Eligibility Criteria:
Inclusion Criteria:
* At the start of the screening phase, participant must meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) or recurrent major depressive disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the Mini International Neuropsychiatric Interview (MINI). In the case of single-episode MDD, the participant must be diagnosed with persistent depressive disorder, which meets criteria of major depressive episode for a continuous duration of greater than or equal to (\>=)2 years, and the same physician from the site must be examining the participant for \>=2 years continuously as a primary care physician of the participant
* The participant's current major depressive episode, depression symptom severity (MADRS total score greater than or equal to \[\>=\] 28 required), and antidepressant treatment response in the current depressive episode, must be confirmed using the SAFER interview
* Participant must be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs (including blood pressure), pulse oximetry, and 12-lead electrocardiogram (ECG) performed in the screening phase
* A woman of childbearing potential must have a negative highly sensitive serum Beta (β) human chorionic gonadotropin \[β-hCG\] test at the start of the screening phase and a negative urine pregnancy test must be obtained before the first dose of study drug on Day 1 of the double-blind induction phase prior to randomization
* Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
Exclusion Criteria:
* Participant has received vagal nerve stimulation or has received deep brain stimulation in the current episode of depression
* Participant previously received esketamine or ketamine as treatment for their MDD
* Participant has homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 6 months prior to the start of the screening phase
* Participant has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria, except nicotine or caffeine, within 6 months before the start of the screening phase
* Participant has a current or past history of seizure disorder (uncomplicated childhood febrile seizures with no sequelae are not exclusionary)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
64 Years
Study:
NCT02918318
Study Brief:
Protocol Section:
NCT02918318