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 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT03697603
Eligibility Criteria:
Inclusion Criteria:
* Outpatients, or inpatients at the time of informed consent whose treatment status can be successfully shifted to outpatient status before enrollment in the antidepressant treatment period
* Male and female patients ≥ 20 to \< 65 years of age (at the time of informed consent)
* Patients who have a level of comprehension sufficient to allow them to give written informed consent to all of the observation/examination/evaluation items specified in the protocol, and who can understand the contents of the trial
* Patients with a DSM-5 classification-based diagnosis of "major depressive disorder, single episode" or "major depressive disorder, recurrent episode," and whose current episode has persisted for at least 8 weeks
Exclusion Criteria:
* Women who are pregnant or breastfeeding or who have positive pregnancy test (urine) results at screening
* Sexually active male subjects or sexually active female subjects of childbearing potential, who will not agree to practice 2 different methods of birth control or to remain abstinent during the trial and for 30 days after the final
IMP administration. For birth control, 2 of the following methods must be used:
vasectomy, tubal ligation, vaginal diaphragm, intra-uterine contraceptive device (IUD), oral contraceptives, or condom with spermicide.
* Patients with a treatment history showing that all antidepressants (including those not used for the current major depressive episode) cannot be tolerated
* Patients with a history of electroconvulsive therapy
* Patients with a diagnosis of any of the following diseases according to DSM-5
1. Neurocognitive disorders
2. Schizophrenia spectrum and other psychotic disorders
3. Bipolar and related disorders
4. Feeding and eating disorders
5. Obsessive-compulsive disorder
6. Panic disorder
7. Posttraumatic stress disorder
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
64 Years
Study:
NCT03697603
Study Brief:
Protocol Section:
NCT03697603