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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT04658420
Eligibility Criteria:
Inclusion Criteria:
* Adults age 18-64
* DSM-IV diagnosis of depressive episode as determined by the Mini International neuropsychiatric Interview criteria, and Montgomery Asberg Depression Rating Scale ≥ 28
* Suicidal ideation at baseline as and positive suicidal ideation defined as Scale for Suicidal Ideation score ≥4.
* Diagnosis of Major depressive disorder, bipolar disorder, or substance induced mood disorder will be included.
Exclusion Criteria:
* Active psychotic symptoms
* Current manic episode
* Previous diagnosis of Schizophrenia or Schizoaffective disorder
* Previous diagnosis of Intellectual disability or Autism Spectrum Disorder
* Previous diagnosis of Major Neurocognitive Disorder
* History of ketamine abuse or dependence
* Hypersensitivity to esketamine, ketamine, or any of the excipients.
Uncontrolled clinically significant medical conditions such as:
* Respiratory illness requiring the use of oxygen
* Previously documented prolonged QTc interval
* Current Aneurysmal vascular disease
* Arteriovenous malformation
* Intracerebral hemorrhage
* Unstable cardiac disease including history of myocardial infarction
* Positive urine pregnancy test
* Previous treatment of depression with Ketamine or Esketamine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT04658420
Study Brief:
Protocol Section:
NCT04658420