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:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-24 @ 2:45 PM
NCT ID:
NCT03968159
Eligibility Criteria:
Inclusion Criteria:
1. Adult patients, aged 18 years and above
2. A clinical diagnosis of major depressive disorder (MDD)
3. Is being treated with one of the following SSRI or SNRI antidepressants:
1. Citalopram
2. Escitalopram
3. Paroxetine
4. Fluoxetine
5. Sertraline
6. Duloxetine
7. Venlafaxine
8. Desvenlafaxine
9. Venlafaxine XR
4. Inadequate response to SSRI/SNRI antidepressant treatment is confirmed
5. If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential OR must agree to use acceptable methods of contraception
Exclusion Criteria:
1. Has a history of psychotic disorder or is currently being treated or requires treatment for post-traumatic stress disorder, acute stress disorder, panic disorder, or obsessive compulsive disorder
2. Has current evidence of delirium or an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that would affect the patient's ability to participate in the program
3. Has a known history or symptoms of long QT syndrome
4. Is determined to be inappropriate for the study for any reason
Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03968159
Study Brief:
Protocol Section:
NCT03968159