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 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT00246233
Eligibility Criteria:
Inclusion Criteria:
* Currently having a Major Depressive Disorder episode without psychotic features
* Has had an inadequate response to at least one but not more than 3 antidepressants given for 4 weeks
* Is currently treated with an antidepressant for the past 4 weeks
* Has a Montgomery Asberg Depression Rating Scale (MADRS) total score greater than or equal to 20, lassitude score of greater than or equal to 2 and a suicidal thought score less than 4
* Has a Clinical Global Impression of Severity (CGI-S) score greater than or equal to 4
Exclusion Criteria:
* Has a current diagnosis of schizophrenia, bipolar disorder, dementia, psychosis, obsessive-compulsive disorder, post-traumatic stress disorder, panic disorder, Attention Deficit Hyperactivity Disorder (ADHD), anorexia nervosa and/or bulimia nervosa, or a history of ADHD, anorexia nervosa and/or bulimia nervosa
* Agitated during the current depressive episode
* Has significant abnormal personality traits, which could interfere with function
* Has a history of substance abuse and or dependence within 6 months prior to screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00246233
Study Brief:
Protocol Section:
NCT00246233