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 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT01473394
Eligibility Criteria:
Inclusion Criteria:
* Men and women, 18-70 years of age.
* Currently meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder.
* The patient's current major depressive episode must be at least 8 weeks and no longer than 12 months in duration.
Exclusion Criteria:
* Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.
* Patients with a history of meeting DSM-IV-TR criteria for any:
* manic, hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic, or mixed episode;
* any depressive episode with psychotic or catatonic features;
* panic disorder with or without agoraphobia;
* obsessive-compulsive disorder;
* schizophrenia, schizoaffective, or other psychotic disorder;
* bulimia or anorexia nervosa;
* presence of borderline personality disorder or antisocial personality disorder;
* mental retardation, dementia, amnesia, or other cognitive disorders;
* patients who are considered a suicide risk.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01473394
Study Brief:
Protocol Section:
NCT01473394