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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT00384033
Eligibility Criteria:
Inclusion Criteria:
* A primary diagnosis of Major Depressive Disorder, single or recurrent episode, without psychotic features.
* Depressive symptoms for at least 30 days before the screening visit.
* Outpatient men and women at least 18 years of age.
Exclusion Criteria:
* Significant risk of suicide based on clinical judgment, including common suicidal thoughts and suicide having been considered as a possible solution even without specific plans or intent.
* Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation.
* Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder; b) current (within 12 months before baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder; c) presence (within 12 months before baseline) of a clinically important personality disorder as assessed during the psychiatric assessments.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00384033
Study Brief:
Protocol Section:
NCT00384033