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 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT04021433
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with unipolar/bipolar depression with MADRS Score\>= 20
* Inadequate response to \>= 3 adequate treatment trials \[\>=2 trials in the present episode\]
* If on psychopharmacological Tx, it should be stable since 4 weeks prior to enrollment
* QTc WNL
Exclusion Criteria:
* Hypersensitivity to ketamine
* Other major psychiatric diagnosis
* High suicidality
* Unstable physical illness
* S/P CVA / brain SOL
* Pregnant or breast feeding women
* Illicit drug/alcohol abuse during last year
* History of ketamine abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04021433
Study Brief:
Protocol Section:
NCT04021433