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 @ 1:21 PM
Ignite Modification Date:
2025-12-24 @ 1:21 PM
NCT ID:
NCT01034995
Eligibility Criteria:
Inclusion criteria:
* Patients with a diagnosis of major depressive disorder, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria (296.3) and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI).
Exclusion criteria:
* Inpatient hospitalization at screening
* Symptoms of depression present for \<30 days or \>2 years
* Significant suicide risk
* Mild depression as measured by standard clinical research scales
* History of failure to respond to antidepressant treatment
* Other psychiatric conditions that could obscure the results of the study
* For women of child-bearing potential, the unwillingness to use highly effective means of birth control
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT01034995
Study Brief:
Protocol Section:
NCT01034995