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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT03678194
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 65 years;
* Fulfilling the Diagnostic and Statistical Manual version IV (DSM-IV) criteria of depression assessed by the Structured Clinical Interview;
* Patients started their antidepressant treatment less than 5 days before inclusion;
* Patient treated in an outpatient setting;
* Patient informed of the diagnosis of his disease;
* Informed patient with written consent.
Exclusion Criteria:
* A current mental or psychiatric impairment or disease (schizophrenia, bipolar disorder) that required psychotropic medication or inpatient treatment on a psychiatric ward;
* A history of psychosis, including schizophrenia, bipolar I or bipolar II disorder, and major depressive disorder with psychotic features;
* Cognitive deficit and not thus being able to comprehend the informed consent and study procedure;
* Patients with somatic, cognitive or other disorders preventing the use of the device (deafness, impaired vision, illiteracy….);
* Non-comprehension of the French language
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03678194
Study Brief:
Protocol Section:
NCT03678194